Suture passer devices and methods

ABSTRACT

Devices, systems and methods for passing a suture. In general, described herein are suturing devices, such as suture passers, as well as methods of suturing tissue. These suture passing devices may include dual deployment suture passers in which a first distal jaw member is moveable at an angle with respect to the longitudinal axis of the elongate body of the device and the second distal jaw member is retractable proximally to the distal end region of the elongate body and/or the first jaw member. Also described herein are suture passers in which the tissue penetrator passing the suture travels in an approximately sigmoidal pathway, with the distal end of the tissue penetrator extending distally from one jaw of the device.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is continuation of U.S. patent application Ser.No. 13/462,773, titled “SUTURE PASSER DEVICES AND METHODS,” filed May 2,2012, Publication No. US-2012-0283754-A1, which is acontinuation-in-part of U.S. patent application Ser. No. 13/323,391,titled “SUTURE PASSER DEVICES AND METHODS,” filed on Dec. 12, 2011,Publication No. US-2012-0283753-A1.

U.S. patent application Ser. No. 13/462,773 also claims priority to thefollowing provisional patent applications: U.S. Provisional PatentApplication No. 61/483,200, titled “MENISCUS REPAIR,” filed on May 6,2011, and U.S. Provisional Patent Application No. 61/511,922, titled“MENISCUS REPAIR,” filed on Jul. 26, 2011.

All of these applications are herein incorporated by reference in theirentirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The methods, devices and systems described herein may be used to suturetissue, particularly in difficult to access regions. In particular,described herein are highly maneuverable suture passers configured to bedeployed around a target tissue to be sutured.

BACKGROUND

Suturing of tissue during surgical procedures is time consuming and canbe particularly challenging in difficult to access body regions andregions that have limited clearance, such as regions partiallysurrounded or covered by bone. For many surgical procedures, it isnecessary to make a large opening in the human body to expose the arearequiring surgical repair. However, in many cases, accessing the tissuein this manner is undesirable, increasing recovery time, and exposingthe patient to greater risk of infection. Suturing instruments (“suturepassers” or “suturing devices”) have been developed to assist inaccessing and treating internal body regions, and to generally assist aphysician in repairing tissue. Although many such devices are availablefor endoscopic and/or percutaneous use, these devices suffer from avariety of problems, including limited ability to navigate and beoperated within the tight confines of the body, risk of injury toadjacent structures, problems controlling the position and/or conditionof the tissue before, during, and after passing the suture, as well asproblems with the reliable functioning of the suture passer.

For example, some surgical instruments used in endoscopic procedures arelimited by the manner in which they access the areas of the human bodyin need of repair. In particular, the instruments may not be able toaccess tissue or organs located deep within the body or that are in someway obstructed. In addition, many of the instruments are limited by theway they grasp tissue, apply a suture, or recapture the needle andsuture. Furthermore, many of the instruments are complicated andexpensive to use due to the numerous parts and/or subassemblies requiredto make them function properly. Suturing remains a delicate andtime-consuming aspect of most surgeries, including those performedendoscopically.

For example, some variations of suture passers, such as those describedin U.S. Pat. No. 7,377,926 to Taylor, have opposing jaws that open andclose over tissue. One, or in some variations, both, jaws open,scissor-like, so that tissue may be inserted between the open jaws.Unfortunately, such devices cannot be adequately positioned for use inhard to navigate body regions such as the joints of the body, includingthe knee (e.g., meniscus) and the shoulder.

The meniscus is a C-shaped piece of fibrocartilage which is located atthe peripheral aspect of the joint (e.g., the knee) between the condylesof the femur and the tibia on the lateral and medial sides of the knee.The central two-thirds of the meniscus has a limited blood supply whilethe peripheral one third typically has an excellent blood supply. Acutetraumatic events commonly cause meniscus tears in younger patients whiledegenerative tears are more common in older patients as the meniscibecome increasingly brittle with age. Typically, when the meniscus isdamaged, a torn piece of meniscus may move in an abnormal fashion insidethe joint, which may lead to pain and loss of function of the joint.Early arthritis can also occur due to these tears as abnormal mechanicalmovement of torn meniscal tissue and the loss of the shock absorbingproperties of the meniscus lead to destruction of the surroundingarticular cartilage. Occasionally, it is possible to repair a tornmeniscus. While this may be done arthroscopically, surgical repair usinga suture has proven difficult to perform because of the hard-to-reachnature of the region and the difficulty in placing sutures in a way thatcompresses and secures the torn surfaces.

Arthroscopy typically involves inserting a fiberoptic telescope that isabout the size of a pencil into the joint through an incision that isapproximately ⅛ inch long. Fluid may then be inserted into the joint todistend the joint and to allow for visualization of the structureswithin that joint. Then, using miniature instruments which may be assmall as 1/10 of an inch, the structures are examined and the surgery isperformed.

FIGS. 21A, 21B and 22 illustrate the anatomy of the meniscus in thecontext of a knee joint. As shown in FIG. 22 the capsule region (theouter edge region of the meniscus) is vascularized. Blood enters themeniscus from the menisculocapsular region 211 lateral to the meniscus.A typical meniscus has a flattened bottom (inferior surface or side) anda concave top (superior surface or side), and the outer cross-sectionalshape is somewhat triangular. The outer edge of the meniscus transitionsinto the capsule. FIG. 23 illustrates the various fibers forming ameniscus. As illustrated in FIG. 23, there are circumferential fibersextending along the curved length of the meniscus, as well as radialfibers, and more randomly distributed mesh network fibers. Because ofthe relative orientations and structures of these fibers, and thepredominance of circumferential fibers, it may be beneficial to repairthe meniscus by suturing radially (vertically) rather thanlongitudinally or horizontally, depending on the type of repair beingperformed.

For example, FIGS. 24A-24E illustrate various tear patterns or injuriesto a meniscus. Tears may be vertical/longitudinal (FIG. 24A), oblique(FIG. 24B), degenerative (FIG. 24C), including radially degenerative,transverse or radial (FIG. 24D) and horizontal (FIG. 24E). Most priorart devices for suturing or repairing the meniscus are only capable ofreliably repairing vertical/longitudinal tears. Such devices are nottypically useful for repairing radial or horizontal tears. Furthermore,prior art device mechanisms have a high inherent risk for iatrogenicinjury to surrounding neurovascular structures and chondral surfaces.

Thus, there is a need for methods, devices and systems for suturingtissue, particularly tissue in difficult to access regions of the bodyincluding the joints (shoulder, knee, etc.). In particularly, it hasproven useful to provide a device that may simply and reliably reach andpass sutures within otherwise inaccessible tissue regions. Finally, itis useful to provide a suturing device that allows the tissue to besutured to be held within an adjustable jaw so that it can bepredictably sutured, and done so in a manner that protects fragilesurrounding tissues from iatrogenic injury. The methods, devices andsystems described herein may address this need.

SUMMARY OF THE DISCLOSURE

The present invention relates to devices, systems and methods forsuturing tissue, including a torn meniscus. In general, described hereinare suturing devices, such as suture passers, as well as methods ofaccessing and repairing tissue using these suture passers, includingmethods of suturing tissue. The device and methods described hereinallow methods of suturing and repairing tissue that were previouslyimpossible or impractical to perform during a surgical procedure.

In particular, the suture passers described herein may be configured sothat a tissue penetrating element (tissue penetrator, needle, etc.) isconfigured to travel in an approximately sigmoidal pathway when passinga suture. For example, the suture passer may be configured so that thetissue penetrator extends first distally within a first jaw member ofthe suture passer, then deflects from this distal direction to travelnearly perpendicular to the distal direction and across the mouth of thesuture passer (and through a tissue held in the mouth of the suturepasser); the tissue penetrator is then deflected to continue to extenddistally within a second jaw member and eventually extend out of adistal opening in the second jaw member.

In some variations, the suture passers described herein may also beconfigured as dual deployment suture passers, because the tissueengaging region of the suture passer comprises a distal-facing openingformed between two jaws (a first jaw member and a second jaw member),and each jaw member moves (is deployed) independently with a differenttype (e.g., axis, plane, range, etc.) of motion. Many of the devicesdescribed herein may also be referred to as clamping/sliding suturepassers, because the first jaw member acts to clamp onto the tissue, bychanging the angle of the first jaw member relative to the more proximalelongate body region of the device, and the second jaw member slides,moving axially relative to the more proximal elongate body region of thedevice.

Thus, in many of the dual deployment suture passers described herein,the first jaw member generally extends distally from a proximal elongatebody region; the angle of the first jaw member relative to the proximalelongate body region is adjustable. These dual deployment suture passersalso have a second jaw member that may be moved from a position proximalto the first jaw member and/or proximal to the distal end of theelongate body region to a distal position to form a distal-facing jawopening with the first jaw member.

Because of this novel jaw movement, a dual deployment suture passer mayreadily access and be positioned around tissue to be sutured in ways notpossible with more traditional suture passers. Generally a dualdeployment suture passer may be positioned within the tissue byadjusting the angle of the first jaw member to help avoid non-targettissue as the device is advanced so that the first jaw member isadjacent to the target tissue. The second jaw member may then beextended distally from the proximal position (e.g., by sliding axially,by swinging distally, etc.) so that the tissue is held between the firstand second jaw members in a distal-facing jaw opening. The tissue to besutured may then be clamped securely between the first and second jawmembers (e.g., by adjusting the angle of the first jaw member), and asuture may be passed between the two by extending a tissue penetratorfrom within one of the first or second jaw members, across the openingand through the tissue, to either drop off or pick up a suture at theopposite jaw member. The tissue penetrator can then be retracted backinto the jaw member that houses it.

For example, described herein are methods of arthroscopically placing asuture. The suture may be placed entirely arthroscopically. For example,two or fewer incisions may be made into the body (e.g., knee, shoulder,etc.), and a camera and suture passer may be placed within the knee. Inany of these methods, the suture may be placed by independently orsequentially moving a first distal jaw member through a first range ofmotion before, during or after placing the distal end of the suturepasser into the tissue region. A second jaw member is typically heldproximally to the first jaw member either within or aligned with themore proximal elongate body region of the suture passer. Afterpositioning the distal end of the suturing device, including thedistally-extending first jaw member against the target tissue to besutured, the second jaw member may be advanced distally until it ispositioned opposite from the first jaw member. The tissue may be securedbetween the first and second jaw members. In general the second jawmember may be moved into position by moving the second jaw member in apath of motion that is different from that of the first jaw member. Forexample, the first jaw member may be hinged to move at an angle relativeto the elongate body of the device, while the second jaw member extendsdistally (and retracts proximally) by sliding axially relative to theelongate body of the device.

For example, described herein are dual deployment suture passer devices.In some variations these devices include: an elongate body having aproximal end region and a distal end region; a first jaw memberextending from the distal end region of the elongate body and configuredfor angular movement relative to the elongate body; a second jaw memberconfigured to extend axially relative to the elongate body, the secondjaw configured to form an opening with the first jaw member when thesecond jaw member is axially extended; and a tissue penetratordeployably held within either the first or second jaw member andconfigured to pass a suture between the first and second jaw members byextending and retracting between the first and second jaw members whenthe first and second jaw members form the opening.

In some variations, the second jaw member may be contained within theelongate body; in other variations, it is held outside of the elongatebody (e.g., secured adjacent to the outside of the elongate body). Theelongate body may be straight, curved, or bendable; in someconfigurations the elongate body is tubular and extends as an elongatetube. In general, the elongate body may have any appropriatecross-section, including round, oval, square, triangular, or the like.The cross-section of the elongate body may be uniform, or it may varyalong its length. In some variations, the elongate body may be narrowertowards the distal end, which may allow the device to be inserted intovarious regions of the body.

In general, the device may be configured so that the tissue penetratorextends between the first and second jaw members when they are fullydeployed distally. In this configuration, they may be referred to asdistal opening or having a distal-facing opening. In some variations thefirst jaw member and the second jaw member are deployed or deployable toform a distal facing opening into which the target tissue can bepositioned or held. In some variations the distal opening formed betweenthe jaws is formed around the target tissue by placing the first or thesecond jaw members adjacent the target tissue and moving the other jawmember (e.g., second or first jaw members) on the opposite side of thetarget tissue.

The tissue penetrator may be any appropriate tissue penetrating member.For example, the tissue penetrator may be a needle or tissue penetratingprobe. The tissue penetrator may include a suture engagement region forreleaseably engaging a suture. In some variations the suture engagementregion is a hook, notch, clamp, grasper, eyelet, slot, or the like. Thesuture engagement region may be positioned at or near the distal end, orjust proximal to the distal end of the tissue penetrator. The distal endof the tissue penetrator may be sharp (e.g., pointed, beveled, etc.) orit may be substantially dull. The tissue penetrator may be a metal,polymeric, alloy, ceramic, composite, or other material. Shape memory orsuperelastic materials, including superelastic alloys (such as Nitinol)may be used. Thus, as mentioned, the device may include a sutureengagement region at or near a distal tip of the tissue penetratorconfigured to couple with a suture.

In general, the tissue penetrator may extend between the first andsecond jaw members only when the first and second jaw members arepositioned to form an opening between which tissue may be held. In somevariations the suture passer includes a lock or other element preventingor limiting (e.g., a limiter) the tissue penetrator motion fromextending between or beyond the first and second jaw members.

During operation, the tissue penetrator generally extends from eitherthe first or second jaw members, and across the opening between thefirst and second jaw members (including through any tissue between thejaw members), to engage with a suture retainer on the opposite jaw. Thesuture retainer may hold a suture so that it can be engaged (grabbed) bythe tissue penetrator. For example, in some variations the tissuepenetrator extends across the opening between the first and second jawmembers until it engages with a suture held by the opposite jaw member(e.g., in a suture retainer); thereafter the tissue penetrator can beretracted back across the opening and pull the suture with it. In somevariations the suture is preloaded onto the tissue penetrator and thesuture retainer grabs the suture from the tissue penetrator (or thetissue penetrator deposits the suture in the suture retainer) and holdsthe suture in/on the opposite jaw as the tissue penetrator is retractedback across the opening and through any tissue there between.

The motion of the tissue penetrator may be regulated to prevent thetissue penetrator from extending beyond the opening formed between thefirst and second jaw members as it extends across this opening. Inparticular, a dual deployment suture passer may be configured to preventthe tip of the tissue penetrator from extending beyond the outside of ajaw member. Extending beyond the jaw member may result in damage tosurrounding (non-target) tissues. For example, the suture passer may beconfigured so that the extent of travel of the tissue penetrator islimited based on how “open” the jaw members are; in variations in whichthe size of the opening can be modified by adjusting the angle of thefirst jaw member relative to the elongate body of the device, a limitermay prevent the tissue penetrator from extending further beyond the sideof a jaw member opposite from the jaw member housing the tissuepenetrator. For example, the tissue penetrator may be configured toextend and retract between the first and second jaw members withoutextending substantially beyond a lateral side of the first or second jawmembers opposite the opening. Thus, the devices described herein mayalso include a movement limiter configured to limit the movement of thetissue penetrator based on a position of the first jaw member, thesecond jaw member or both the first and second jaw members, relative tothe elongate body.

In some variations the limiter (e.g., a travel limiter) may be employedto keep the tissue penetrator from extending beyond the opening andopposite jaw member. For example, a limiter may include a barrier,block, cage, or the like on the opposite jaw member preventing the tipof the tissue penetrator from extending beyond the jaw member when thetissue penetrator is extended across the opening.

Thus, the suturing device may also include a travel limiter configuredto prevent the tissue penetrator from extending substantially beyond alateral side of the first or second jaw members opposite the opening.

One of the jaw members (e.g., the second jaw member) may be configuredto move axially by extending distally or retracting proximally from thedistal end region of the elongate body. Thus, the second jaw member mayextend parallel to the long axis of the elongate body; in curvedvariations of the elongate body, the second jaw member extends distallyin the direction continuing the distally moving trajectory of theelongate body. The second jaw member may extend axially from within theelongate body, or from adjacent to the elongate body. In some variationsthe entire second jaw member may retract within the elongate body.

In some variations, the opening formed between the first and second jawmembers by extending the second jaw member distally is a distal-facingopening, as described above. In some variations the device includes aholdfast to hold one or both jaw element(s) in a fixed position; theholdfast may be released or engaged by user control. For example, thesuturing device may include a first and/or second jaw holdfastconfigured to hold the first and/or second jaw members in a fixedposition relative to the elongate body. In one variation, the deviceincludes a first jaw holdfast configured to hold the first jaw member inan angular position relative to the elongate body and/or a second jawholdfast to hold the second jaw element in a fixed axial positionrelative to the elongate body.

Any of the device variations described herein may include a handle atthe proximal end of the device. The handle may be controlled by a user(e.g., surgeon) to actuate the various elements of the device, includingthe first jaw member, the second jaw member, and the tissue penetrator.The handle may therefore include one or more controls. For example, thedevice may include a first control for controlling the angular positionof the first jaw member relative to the elongate body and a secondcontrol for controlling the axial position of the second jaw memberrelative to the elongate body. These controls may be on the proximalhandle.

The device may also include an indicator for indicating when the secondjaw is in a predetermined axially extended position relative to theelongate body. The indictor may be visual, tactile, aural, or the like,including some combination of these. In some variations a separateindicator is not necessary; the full extension of the second (or first)jaw member may be the fully engaged position. Thus, when furtheractuation of the control (e.g., squeezing a trigger, moving a level,dial, or the like) does not result in any further actuation. In somevariations the control may “stop” when the jaw member is fully extended.

Thus, in some variations, the device includes a proximal handle havingcontrols for controlling at least one of the angular movement of thefirst jaw member, the axial movement of the second jaw member or theextension and retraction of the tissue penetrator.

Also described herein are suture passer devices (e.g., a dual deploymentsuture passers) comprising: an elongate body having a proximal endregion and a distal end region; a first jaw member extending from thedistal end region of the elongate body and configured for angularmovement relative to the elongate body; a second jaw member configuredto extend distally or retract proximally from the distal end region ofthe elongate body; and a tissue penetrator configured to pass a suturebetween the first and second jaws and further configured to extend andretract between the first and second jaw members when the second jawmember is extended distally to form a distal-facing opening with thefirst jaw member.

Any of the features described above may be included in these variationsas well. For example, the device may also include a suture engagementregion near a distal tip of the tissue penetrator, the suture engagementregion configured to couple with a suture. In some variations the devicealso includes a movement limiter configured to limit the movement of thetissue penetrator based on a position of the first jaw member, thesecond jaw member or both the first and second jaw members.

Also described herein are suture passer devices including: a hingedfirst jaw member extending from a distal end of an elongate body andconfigured to controllably bend relative to a longitudinal axis of theelongate body; an axially sliding second jaw member configured to extenddistally and retract proximally relative to the distal end of theelongate body to form a distal-facing opening with the first jaw memberwhen the second jaw member is extended distally; a tissue penetratorhoused within the second jaw member and configured to extend across thedistal-facing opening to the first jaw member; a suture engagementregion disposed near a distal end of the tissue penetrator andconfigured to engage a suture; and a travel limiter configured to engagethe tissue penetrator and prevent the tissue penetrator from extendingbeyond a lateral side of the first or second jaw members opposite thedistal-facing opening.

Although many of the device variations just described include a secondjaw member that is axial movable, in some variations the second jawmember is movable in other dimensions in addition to, or alternativelyto, the axial direction. Generally the second jaw member is movable in adirection that is different from the manner of movement of the first jawmember, and extends the second jaw member from a position in which thedistal end (e.g., tip) region of the second jaw member is proximal tothe distal end of the elongate body. Movement of the second jaw membermay be independent of the movement of the first jaw member.

Also described herein are methods of suturing a tissue, the methodcomprising: moving a first jaw member of a dual deployment suture passerso that the first jaw member extends distally from a proximal elongatebody region of the suture passer at an angle with respect to alongitudinal axis of the proximal elongate body region; positioning thefirst jaw member adjacent to a tissue to be sutured; extending a secondjaw member of the suture passer distally relative to the elongate bodyregion to form a distal-facing opening between the first and second jawmembers, so that the tissue to be sutured is within the distal-facingopening; and passing a suture through the tissue within thedistal-facing opening by moving a tissue penetrator coupled to a suturebetween the first and second jaw members.

The method may also include the step of preventing the tissue penetratorfrom extending beyond a lateral side of the first or second jaw membersopposite the distal-facing opening when passing the suture. In somevariations, the method also includes the step of retracting the secondjaw member proximally relative to the elongate body and withdrawing thesuture passer from the tissue.

This method may be used to treat (e.g., suture) as part of a variety oftreatments, including, but not limited to, repair of a torn meniscus,repair of a torn ACL, labral tear repair, hip labrum repair, spinal discrepair, etc. In any of these variations, the method of treatment (methodof suturing tissue) may include the step of positioning the first jawadjacent to the tissue to be sutured, such as the meniscus, labrium,ACL, spinal disc/annulus, etc. For example, the step of positioning thefirst jaw member may comprise positioning the first jaw member adjacentto meniscus tissue.

These devices and methods may be used as part of a minimally invasive(e.g., percutaneous) or open procedure. For example, the method ofsuturing may also include the step of percutaneously inserting thesuture passer near the tissue to be sutured.

The step of passing the suture through the tissue may comprise extendingthe tissue penetrator from the second jaw member through the tissue tothe first jaw member, engaging the suture held in the first jaw memberand retracting the tissue penetrator back to the second jaw member whileholding the suture with the tissue penetrator. In some variations, thestep of passing the suture through the tissue comprises extending thetissue penetrator coupled to a suture from the second jaw member throughthe tissue to the first jaw member, engaging the suture with a sutureretainer in the first jaw member and retracting the tissue penetratorback to the second jaw member.

Any of the suture passer devices described herein may be configured toinclude a tissue penetrator that travels in an approximately sigmoidalpathway. Further, any of these devices may be configured so that thetissue penetrator extends distally from one of the jaw members. Forexample, in some variations the suture passer is configured so that thetissue penetrator extends distally through a distal opening in one jawmember of the suture passer after extending across a distal-facing mouthformed by a pair of jaw members.

For example, described herein are suture passer devices having asuture-passing tissue penetrator that travels in a sigmoidal pathway.The suture passer device may include: a first jaw member extendingdistally from an elongate body, wherein the first jaw member includes adeflection surface and a distal opening; a second jaw member extendingdistally from the elongate body, wherein the first jaw member and thesecond jaw member form a distal-facing mouth; and a tissue penetratorconfigured to extend from the second jaw member, across thedistal-facing mouth, into the first jaw member, deflect against thedeflection surface and extend distally from the distal opening of thefirst jaw member.

In general, the suture passer may push (or in some variations pull orpush and pull) a suture with the tissue penetrator through the tissuefrom one jaw member to the other. For example, in some variations thedevice includes a suture stripper in the first jaw member configured tostrip a suture from the tissue penetrator and retain the suture in thefirst jaw member. A suture stripper may be configured as a leaf springelement that strips a suture from the tissue penetrator and retains thesuture in the first jaw member; the tissue penetrator may push againstand pass the stripper, displacing it, but causing the suture to be heldor caught by the stripper and secured within the jaw member, even whenthe tissue penetrator is retracted back across the mouth formed by thejaws of the device.

As mentioned, in some variations the device is configured so that thefirst jaw and the second jaw are separately movable and thereforeindependently adjustable. For example, the first jaw member may beconfigured to pivot relative to the distal end region of the elongatebody, and the second jaw member may be configured to slide distally andproximally relative to the elongate body. In any of these variations,the device may include a proximal handle comprising a first control forcontrolling the angle of the first jaw member relative to the elongatebody and a second control for controlling distal and proximal extensionof the second jaw member.

Any of the devices described herein may include a suture retainer regionon the tissue penetrator that is configured to hold a length of sutureas the tissue penetrator extends between the first and second jawmembers. The suture retainer region may comprise a lateral cut-outregion of the tissue penetrator (e.g., configured as a hook, catch, orthe like).

As mentioned, the tissue penetrator may typically extend from the distalend of the jaw member after crossing the mouth formed by the pair ofjaws. Extending distally may allow the tissue penetrator to extend morefully from a first jaw member, across the distal facing mouth and mayfacilitate transferring the suture into a suture receiving region(suture dock or receiver) on the opposite jaw. By extending the distaltip of the tissue penetrator distally, the tissue penetrator may preventthe tip from damaging adjacent (lateral) tissue, and fit into protectedor low-risk anatomical regions. This is particularly true when thedevice is used in regions such as the joints. The device may beparticularly well suited to repair a meniscus, as discussed herein. Thetissue penetrator may extend any appropriate distance distally from theopening at the distal end of the jaw member. For example, in somevariations, the tissue penetrator may be configured to extend distallyfrom the distal opening of the tissue penetrator by more than about 1 mm(or more than about 2 mm; more than about 3 mm, between about 0.5 mm andabout 5 mm, etc.).

Any of the devices described herein may be configured so that they canpass more than one length of suture though the tissue sequentially. Forexample, in some variations, it is beneficial to form a loop of suturearound a tissue or tear in a tissue. Thus, the device may be configuredto pass a first end of the suture and then (without removing the suturefrom the tissue) pass the second (opposite) end of the suture at adifferent location on the tissue, thereby forming a loop of suture whichcan be tied off by tying the ends of the suture (suture bights) to eachother or to a device after they've been passed.

In some variations, the second jaw member comprises a suture loadingregion configured to hold a second length of suture while a first lengthof suture is held within a suture retainer region of the tissuepenetrator. Thus, the device may be adapted so that more than one lengthof suture (e.g., the opposite end regions of a suture) can be loaded(including pre-loaded) into the device for passing. In some variationsthe device is configured so that after passing the first length ofsuture, the second length of suture is automatically pushed and loadedinto the suture retainer of the tissue penetrator. Although two or moreseparate sutures may be passed, in some variations the device is adaptedto pass two regions (e.g., the end regions) of the same suture.

For example, in some variations, the suture passer is configured toinclude: a first jaw member extending distally from an elongate body; asecond jaw member extending distally from the elongate body, wherein thefirst jaw member and the second jaw member form a distal-facing mouth; atissue penetrator configured to extend from the second jaw member,across the distal-facing mouth, into the first jaw member, deflectagainst the deflection surface and extend distally from the distalopening of the first jaw member; a first suture retainer region in thetissue penetrator configured to hold a suture in the tissue penetratoras it extends from the second jaw member; a suture loading region in thesecond jaw configured to hold a second suture so that it can be loadedinto the first suture retainer region when the first suture holderregion is empty; and a suture stripper in the first jaw memberconfigured to strip the suture from the tissue penetrator and to retainthe suture within the first jaw member.

In some variations, the suture passer has a suture-passing tissuepenetrator that travels in a sigmoidal pathway and the device includes:a first jaw pivotally coupled to the distally end region of an elongatebody, wherein the first jaw is configured to pivot relative to theelongate member; a deflection surface within the first jaw; a second jawconfigured to slideably extend distally from the elongate body, whereinthe first jaw and the second jaw are configured to form a distal-facingmouth; a tissue penetrator housed within the second jaw and configuredto extend from the second jaw across the distal-facing mouth and intothe first jaw, deflect against the deflection surface, and extenddistally from a distal opening in the first jaw; and a suture retainerregion on the tissue penetrator configured to retain a suture as thetissue penetrator is extended across the distal-facing mouth. Asmentioned above, in some variations, the device is configured so thatthe pivoting motion of the first jaw is independent of sliding motion ofthe second jaw.

As mentioned, any of these suture passers may include a suture stripper(e.g., in the first jaw) that is configured to strip a suture from thetissue penetrator and retain the suture in the first jaw. For example,the suture stripper may be a leaf spring element configured to strip asuture from the tissue penetrator and retain the suture in the firstjaw.

Any of the devices described herein may include a proximal handle. Theproximal handle may include one or more controls for controllingextension/retraction of the tissue penetrator, and/or controls fromcontrolling the motion(s) of the jaws. For example, described herein areproximal handles comprising a first control for controlling pivoting andangle of the first jaw member relative to the elongate body and a secondcontrol for controlling distal and proximal extension of the second jaw.

In general, the suture retainer region may be configured to hold thesuture (or an element coupled to the suture) as it is pulled or pushedthrough the tissue following the path of the tissue penetrator. Forexample, the tissue penetrator may include a suture retainer region thatis a lateral cut-out region of the tissue penetrator. In somevariations, the suture retainer is a hook region for holding a length ofsuture.

Also described herein are methods of using the suture passers describedherein to pass a suture and/or form a loop of suture around a tissue,and particularly a tissue tear. Although a variety of tissues (and/orexplants, implants, graphs, and the like) may be sutured using thesedevices and methods, methods for repairing the meniscus of the knee areillustrated herein. Thus, any of the methods described herein may beused to repair or treat (and generally, suture) a meniscus. The methodsand devices described herein may be performed in an open, semi-open,and/or minimally invasive (e.g., percutaneous) procedure.

For example, described herein are methods of passing a suture throughtissue using a suture passer having a first jaw member and a second jawmember that are configured to form a distal-facing mouth and a suturepasser device having a suture-passing tissue penetrator that travels ina sigmoidal pathway. In some variations, the method may include all orsome of the steps including: extending the tissue penetrator from withinthe second jaw member, across the distal-facing mouth and though thetissue, and into the first jaw member; deflecting the tissue penetratorwithin the first jaw member and extending the tissue penetrator distallyout of a distal opening in the first jaw member; and retracting thetissue penetrator back into the first jaw member, across thedistal-facing mouth and into the second jaw member; wherein the tissuepenetrator carries a suture through the tissue when extending from thesecond jaw member or retracting into the first jaw member.

In some variations, the method includes positioning the tissue withinthe distal facing mouth, for example, by placing the first jaw memberadjacent to one side of the tissue and thereafter extending the secondjaw member distally so that it is adjacent to a second side of thetissue. In some variations, placing the first jaw member adjacent to oneside of the tissue comprises adjusting the angle of the first jaw memberrelative to a proximal shaft region of the suture passer.

Any of these methods may include stripping a suture from the tissuepenetrator while the tissue penetrator is within the first jaw memberand retaining the suture within the first jaw. For example, strippingthe suture may include displacing a suture stripper when extending thetissue penetrator distally within the first jaw member.

Also described herein are methods of passing a suture through tissueusing a suture passer having a first jaw member and a second jaw memberthat are configured to form a distal-facing mouth and a suture passerdevice having a suture-passing tissue penetrator that travels in asigmoidal pathway, the method comprising: positioning the suture passerwith the tissue within the distal facing mouth; extending the tissuepenetrator holding a length of suture from the second jaw member, acrossthe distal-facing mouth, though the tissue, and into the first jawmember; deflecting the tissue penetrator within the first jaw member andextending the tissue penetrator distally out of a distal opening in thefirst jaw member; stripping the length of suture from the tissuepenetrator and retaining the length of suture within the first jawmember; and retracting the tissue penetrator back into the first jawmember, across the distal-facing mouth and into the second jaw member.The method may also include positioning the first jaw member over thetissue to be sutured and then sliding the second jaw member distally toform the distal-facing mouth with the tissue between the first andsecond jaw members of the distal facing mouth.

Also described herein are methods of suturing a tissue using a suturepasser having a first jaw member and a second jaw member that areconfigured to form a distal-facing mouth. For example, the method mayinclude the steps of: positioning the suture passer with a first regionof the tissue between the first and second jaw members of the distalfacing mouth; extending a tissue penetrator containing a first region ofa suture from the second jaw member, across the distal-facing mouth,though the tissue, and into the first jaw member; holding the first endof the suture within the first jaw member and withdrawing the tissuepenetrator back into the second jaw member; repositioning the suturepasser with a second region of the tissue between the first and secondjaw members of the distal facing mouth; extending the tissue penetratorcontaining a second region of the suture from second jaw member, acrossthe distal facing mouth, through the tissue, and into the first jawmember; holding the second region of the suture within the first jawmember and withdrawing the tissue penetrator back into the second jawmember; and withdrawing the suture passer from the tissue and pullingthe first and second regions of the suture.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows one variation of a dual deployment suture passer asdescribed herein.

FIGS. 2A through 2D illustrate actuation of the first jaw member, secondjaw member and tissue penetrator for one variation of a suture passer.

FIG. 3 is a side view of the suture passer shown in FIG. 1.

FIG. 4 is a front perspective view of the suture passer shown in FIG. 3in which the first jaw member is positioned at an angle relative to thelongitudinal axis of the elongate body of the device, and the second jawmember is extended fully distally relative to the elongate body to forma distal-facing jaw opening.

FIG. 5A is a side perspective view of the suture passer variation shownin FIG. 4 with the second jaw member retracted proximally.

FIG. 5B shows the suture passer of FIG. 5A with the second jaw extendeddistally;

FIG. 5C shows FIG. 5B with the outer region of the elongate bodyremoved.

FIG. 6A shows a top perspective view of the suture passer shown in FIG.5A.

FIG. 6B shows a bottom perspective view of the suture passer of FIG. 5B.

FIG. 6C shows a bottom perspective view of the suture passer of FIG. 5C.

FIG. 7A shows a side view of one variation of a tissue penetrator.

FIG. 7B shows a side perspective view of the tissue penetrator of FIG.7A.

FIG. 8 shows the perspective view of FIG. 4 with a tissue penetratorpartially extended between the first and second jaw members, and with asuture loaded in the first jaw member.

FIGS. 9A-9C illustrate actuation of a suture passer such as the oneshown in FIG. 8 to pass a suture from the upper jaw to the lower jaw.

FIG. 10A shows a side view of one variation of the distal end region ofa suture passer, showing a first and second jaw member extended in toform a distal facing opening.

FIG. 10B shows another variation of the distal end region of a suturepasser with the first and second jaw member extended in to form a distalfacing opening.

FIG. 11 illustrates one variation of a first jaw member having a hingeallowing angular motion relative to the long axis of the elongate memberregion of the suture passer.

FIGS. 12A-12E illustrate operation of one variation of a dual deploymentsuture passer configured as a clamping/sliding suture passer.

FIGS. 13A-13C illustrate operation of one variation of a dual deploymentsuture passer configured as a clamping/side-swinging suture passer.

FIGS. 14A-14C illustrate operation of one variation of a dual deploymentsuture passer configured as a clamping/down-swinging suture passer.

FIGS. 15A-15C illustrate operation of one variation of a dual deploymentsuture passer configured as a clamping/complex motion suture passer.

FIGS. 16A-16C illustrate another variation of a dual deployment suturepasser configured so that the distal end of the tissue penetratorextends distally from the first jaw.

FIG. 17A shows one variation of a proximal handle with controls forcontrolling action of a dual deployment suture passer.

FIG. 17B shows another variation of a proximal handle with controls forcontrolling action of a dual deployment suture passer.

FIGS. 18A-18C show another variation of a suture passer as described.

FIGS. 19A-19F illustrate operation of one variation of dual deploymentsuture passer.

FIGS. 20A and 20B show a generic form of a dual deployment suturepasser.

FIGS. 21A and 21B illustrate the anatomy of the meniscus.

FIG. 22 illustrates the anatomy of the meniscus, including the capsuleand associated vascular tissue.

FIG. 23 illustrates the structure of a meniscus.

FIGS. 24A-24E illustrate various tear patterns that may be repairedusing the invention described herein.

FIGS. 25A-25H illustrate the use of a dual deployment suture passer tosuture a torn meniscus.

FIGS. 26A-26H illustrate the use of a dual deployment suture passer tosuture a labral tear.

FIGS. 27A-27G illustrate the use of a dual deployment suture passer torepair a hip labrum.

FIG. 28 shows an exemplary section through a spine showing a normaldisc;

FIG. 29 shows a similar section through a spine having a herniated disc.

FIGS. 30A-F illustrate the use of a dual deployment suture passer torepair a herniated disc.

FIGS. 31A-31F illustrate another example of using a dual deploymentsuture passer to repair a spinal region.

FIGS. 32A-32C illustrate a generic variation of a suture passerincluding a tissue penetrator traveling in a sigmoidal path in which thedistal end of the tissue penetrator extends distally from the upper jaw.

FIG. 33A is another variation of a suture passer having a tissuepenetrator that extends distally from the upper jaw; FIG. 33Billustrates the motion of the upper and lower jaw of the suture passerof FIG. 33A.

FIG. 33C is another variation of a suture passer having a tissuepenetrator that extends distally from the upper jaw; FIG. 33Dillustrates the motion of the upper jaw of the suture passer of FIG.33C.

FIG. 33E is another variation of a suture passer having a tissuepenetrator that extends distally from the upper jaw; FIG. 33Fillustrates the motion of the lower jaw of the suture passer of FIG.33A.

FIG. 34A illustrates different paths for a tissue penetrator in a suturepasser having an upper jaw member that pivots.

FIGS. 34B-34E illustrate sigmoidal paths that may be taken by a tissuepenetrator as described herein.

FIGS. 35A and 35B show top and side views, respectively of one variationof a tissue penetrator.

FIGS. 36A-36E illustrate operation of one variation of a suture passerhaving a tissue penetrator that extends distally from the upper jaw andtravels in a sigmoidal path.

FIGS. 37A-37B show side perspective views of one variation of an upperjaw member for a suture passer such as the suture passer shown in FIG.36A.

FIGS. 38A-38B show side perspective views of another variation of anupper jaw member for a suture passer including a suture stripper.

FIGS. 39A, 39B and 39C show another variation of a suture passer.

FIGS. 40A, 40B, and 40D show top and two side perspective views,respectively of the distal end of the suture passer shown in FIG. 39A.

FIG. 40C illustrates the arrangement of the tissue penetrator and suturestripper in the distal end region of the suture passer of FIG. 39A.

FIGS. 41A-41C show a suture stripper including a stripper plate (FIG.41B) and base (FIG. 41C).

FIGS. 42A and 42B show side perspective views of the distal end regionof a jaw member including a suture stripper.

FIGS. 43A-43E illustrate operation of a suture stripper.

FIGS. 44A-44G and 45A illustrate one method of suturing a tissue in aloop using a suture passer such as the suture passer shown in FIG. 39A.

FIGS. 45B and 45C illustrate suturing complex meniscal tears, includingthose having a radial tear, using a suture passer such as the one shownin FIG. 39A.

FIGS. 46A-46L show another illustrate of a method for suturing meniscaltissue similar to that shown in FIGS. 44A-44G.

FIGS. 47A-47E illustrate one method of loading a suture passer with twoloops of suture that may be sequentially passed by the suture passer.

FIG. 48 shows one variation of a suture handle having a control to aidin loading the suture by adjusting the position of the tissuepenetrator.

FIG. 49 shows one variation of a suture passer and tissue penetratorconfigured to sequentially pass two lengths of suture.

FIGS. 50A and 50B schematically illustrate two variations of suturepassers in which both legs of a loop of suture are held on the same sideof the jaw of the suture passer.

FIG. 51 shows another variation of a suture passer configured tosequentially pass two lengths of suture.

FIG. 52 shows another variation of a suture passer configured to passtwo lengths of suture.

FIGS. 53A-53L illustrate another variation of a method of suturingmeniscal tissue with a suture passer having a suture snare.

FIG. 54A illustrates another variation of a suture passer and FIG. 54Bshows greater detail on the distal end of the suture passer.

FIGS. 55A-55DD illustrate a method of suturing meniscal tissue using thesuture device of FIG. 54A.

FIGS. 56A-56C illustrate variations of a first jaw (e.g., upper jaw) ofa suture passer device having different thicknesses.

FIG. 57 illustrates two variations of second jaw (e.g., lower jaw)members of a suture passer having different thicknesses.

FIG. 58 shows a variation of a suture passer device in which the tissuepenetrator is configured to extend proximally within the jaw memberopposite from the jaw member housing the tissue penetrator.

FIG. 59A shows a top view of one variation of a jaw member in which toloops (bights) of suture have been loaded. FIG. 59B shows a top views ofthe jaw member of FIG. 59A in which the second suture bight is heldtaught by a suture management element. In FIG. 59C the suture bight hasbeen automatically loaded into the suture retainer region of a tissuepenetrator. FIG. 59D shows the same view of the jaw member after thesuture management element has released the suture bight.

FIGS. 59E-59H illustrate the use of a suture management feature tosecure and apply tension to one of the loops of suture loaded into thejaw member of FIG. 59A during loading and operation of a suture passer.

FIG. 60 shows a bottom perspective view of one variation of a suturepasser device similar to the device shown in FIGS. 39A-40D, including asuture cleat holding a suture.

FIGS. 61A and 61B illustrate one variation of a suture managementfeature (e.g., cleat) configured to automatically release one or morelengths of suture during operation of a suture passer.

FIGS. 62A and 62B illustrate another variation of a suture cleat.

DETAILED DESCRIPTION

Described herein are suture passers. In general, these devices may bereferred to as suture passers and/or suturing devices. Differentvariations of the devices described herein may also be referred to assnake-tongue, sigmoidal, dual deployment suture passers, and/orclamping/sliding suture passers.

In general, the suture passers described herein include a first jawmember and second jaw member that extend from the end of an elongatebody region to form a distal-facing mouth into which tissue to besutured fits. In some variations one or both jaws forming the mouth maybe independently moved. FIG. 1 illustrates one variation of a dualdeployment suture passer 100. In this example, the device has a first(upper) jaw member 103 extending distally from the distal end of a moreproximal elongate member 101. A second jaw member 105 is shown extendeddistally beneath the first jaw member 103. A handle 107 is located atthe proximal end of the device and includes multiple controls forindependently controlling the movements of the first jaw member, secondjaw member, and tissue penetrator. The handle in this example alsoincludes a second jaw member lock for locking/unlocking the movement ofthe second jaw member.

The suture passer shown in FIG. 1 is positioned with the first jawmember held at an angle relative to the long axis of the proximalelongate member. The first jaw member in this example is shown having ahinge region 113 about which the first jaw member may be angled relativeto the elongate member. In some variations this hinge region is a pinnedhinge; non-pinned (e.g., living hinges) regions may be used. Anyappropriate articulating region that allows the first jaw member to moveat an angle relative to the proximal portion of the device (e.g., theelongate member) may be used. In some variations this first jaw memberis referred to as an upper jaw member, but alternative variations (inwhich the first jaw member is a lower jaw member) are also possible.

The first jaw member may be actuated by any appropriate mechanism,including a tendon member (e.g., push rod, pull rod, or the like), andmay be held (locked) at any angle (e.g., between 0° and 180° relative toa line extending from the distal end of the elongate body, between about0° and 90°, between about 0° and 60°, etc.). In some variations thedevice has a neutral position during which no force is applied to thecontroller to move the first jaw member, so that the first jaw member isangled “open” (e.g., at 30°, 45°, 50°, 90° or at any angle between about15° and about 90°) relative to the elongate body; actuating the controlon the handle results in the first jaw member moving towards the“closed” position (e.g., reducing the angle with respect to a lineextending from the distal end of the elongate body). In some variationsthe jaw member is in the neutral position when angled with 0°/180°relative to the elongate body.

The first jaw member shown in FIG. 1 also includes a suture retainerregion near the distal end (described in greater detail below). Thissuture retainer region may hold the suture or be configured to hold asuture. In some variations the suture retainer includes a channel orguide for holding the suture in a preferred position. In some variationsthe suture retainer includes a pair of graspers, or deflectable membersinto which the suture may be pushed and held (e.g., handed off from thetissue penetrator). A suture retainer generally holds the suture so thatit can be either removed by the tissue penetrator, or so that a suturecan be passed into the suture retainer from the tissue penetrator. InFIG. 1, the suture retainer is a channel across which the suture extendsso that it can be reliably engaged and pulled down by the tissuepenetrator as described in more detail below. In some variations thesecond jaw member includes a suture retainer, rather than the first jawmember.

The second jaw member is shown in FIG. 1 as a lower jaw member. In thisvariation, the lower jaw member is configured to slide proximallytowards and into the proximal elongate body of the device. The secondjaw member typically moves axially, in the direction of theproximal-distal axis of the suture passer. In some variations the secondjaw member moves axially completely past the distal end of the elongatebody; alternatively, the second jaw member slides axially in theproximal direction only partially (e.g. to align with the hinge regionof the first jaw member). The second jaw member shown in FIG. 1 retractscompletely into, and extends out of, the lower portion of the elongatebody. In some variations the second jaw member moves axially in parallelwith the lower jaw member, or only a portion of the lower jaw memberextends into the elongate body.

A tissue penetrator (not shown in FIG. 1) may be housed within eitherthe first or second jaw member. As described in more detail below, thetissue penetrator may be configured as a needle, wire, knife, blade, orother element that is configured to extend from within either the firstor second jaw members and across the opening between the jaw members toengage a suture retainer and either drop off or pick up a suturetherefrom. In general, the tissue penetrator may be configured tocompletely retract into the jaw member housing. It may be extendedacross the opening between the jaws by actuating a member in the handleto push or otherwise drive it across the opening, and though any tissueheld between the jaws.

The second jaw member 105 shown in FIG. 1 completely houses the tissuepenetrator and includes a deflection region that drives the tissuepenetrator up and out of the second jaw member by deflecting it acrossthe opening between the two.

The elongate body 101 shown in FIG. 1 is illustrated as a relativelystraight cylindrical body, though other shapes may be used. For example,the elongate body may be curved, bent, or angled. In some variations theelongate body is configured to be bent, curved or angled dynamically(e.g. by changing the bend or curve).

The elongate body may be any appropriate length. For example, theelongate body may be between about 6 and about 24 inches long, e.g., 6inches long, 8 inches long, 10 inches long, 12 inches long, etc. Thesuture passers described herein may be used for arthroscopic surgeriesand therefore may be dimensioned for use as such. Thus the diameter ofthe device may be configured to be small enough for insertion into acannula, tube or the like for insertion into the body.

FIGS. 2A-2D illustrate one variation of the distal end region of a dualdeployment suture passer forming a distal-facing opening and extending atissue penetrator across the distal opening. For example, in FIG. 2A thedistal end of the device is shown with the first jaw member 201 (shownhere as an upper jaw member) extended distally at 0° relative to a lineextending from the distal end of the elongate body 203. This “straight”configuration may be helpful for inserting and/or removing the distalend of the device into the tissue (e.g., through a cannula). The firstjaw member can then be bent, or allowed to bend in some variations, atan angle relative to a line extending from the distal end of theelongate body.

In this example, the first jaw member pivots around a hinge point 205,and is controlled by a pulling member 208 that pushes and/or pullsproximally and/or distally to control the bend of the first jaw member.The pulling member may include a shaft, wire, tendon, tube, cannula, orthe like, and may extend to the proximal end of the device where it canbe controlled. The arrow 211 in FIG. 2A illustrates the plane anddirection of motion of the first jaw member.

In FIG. 2B the first jaw member has been moved (or allowed to move) sothat it forms an angle of approximately 30° with a line extending fromthe distal end of the elongate body. The arrow 215 in FIG. 2Billustrates the direction of axial motion that the lower jaw (not yetvisible in FIG. 2B) will be moved. This is illustrated in FIG. 2C, inwhich the lower jaw member 207 has been extended distally from theproximal region of the device. In this example the second jaw member 207is shown fully extended distally relative to the elongate body region203. Although this example shows the second jaw member extending fromcompletely within the elongate body region (as in FIG. 2B), in somevariations the lower jaw member is held outside of the elongate bodyregion, or only partially within the elongate body region. In somevariations the second jaw member is completely retracted proximally sothat much (or all) of the second jaw member is held proximal to thedistal end of the elongate body region 203.

Once the first and second jaw members are completely extended distally(as shown in FIGS. 2C and 2D, the tissue penetrator may be sent acrossthe distal-facing opening 222 as shown in FIG. 2D. Although (asdescribed in greater detail below) in some variations the distal end ofthe tissue penetrator may be configured to extend distally from anopening in a jaw member, in other variations, the tissue penetrator maybe prevented from exiting the opposite side of the jaw member. Forexample, the tissue penetrator may be prevented from extending distallybeyond the jaw member by a limiter (e.g., a travel limiter and/or amovement limiter). In FIG. 2A-2D the first jaw member includes a cage orshield region 232 that prevents the tip of the tissue penetrator fromextending out of the first jaw member where it may cut or damage thenon-target tissue. In some variations the device may also include amovement limiter, which limits the movement of the tissue penetrator sothat it can only extend to just couple with the opposite jaw member (andpass or grab a suture held therein). Since the jaws may be open tovarying positions, a movement limiter may help prevent the tissuepenetrator from overextending even when the first jaw member is onlyslightly angled with respect to a line extending from the distal end ofthe elongate body.

In some variations the tissue penetrator may be prevented from extendingacross the opening between the first and second jaw members unless thesecond (axial moving) jaw member is extended distally relative to theelongate body. This may allow the tissue penetrator to mate properlywith the suture engagement region on the first jaw member. For example,a lock or other mechanism may be used to prevent the tissue penetratorfrom engaging with a control at the proximal end of the device until thesecond jaw member is fully extended.

A side view of the device shown in FIGS. 1-2D is provided in FIG. 3.

FIG. 4 shows a front perspective view of the distal end region of thedevice of FIGS. 1-3 with the second jaw member extended fully distallyand the first jaw member angled slightly (e.g., approximately 30°relative to a line extending distally from the longitudinal axis of theelongate body). In this variation the lower jaw member 403 may beconfigured to fit within the upper jaw member 401 when the two jawmembers are closed down on one another (not shown). Thus the upper(first) jaw member 401 is wider than the lower (second) jaw member 403.The first jaw member in this example also includes optional side windows402. The first jaw member may also include a suture engagement region;in FIG. 4, this suture engagement region includes a channel 409 throughthe midline (extending proximally to distally) and a first 415 andsecond 417 notch or protrusion cut into the first jaw member. A suturemay be wrapped around the first jaw member by passing from the proximalend of the device, under the proximal notch 417 and along the bottom(e.g., the side of the first jaw facing the extended second jaw) aroundthe distal end of the first jaw member and along the top (e.g., the sideof the first jaw facing away from the second jaw) and, under the distalnotch 415 and back up out of the proximal notch 417 so that the suturemay extend distally. This loop of suture held by the suture engagementregion of the jaw member may be held under sufficient tension so thatthe suture may be engaged by the suture engagement region of the tissuepenetrator (e.g., hook, grasper, etc.). In some variations a tensioningmember may be included in the suture engagement region.

In some variations (not shown here) the suture may be contained withinthe elongate body of the device. Alternatively, the suture may be keptoutside of the device. In some variations the suture may be loaded bythe user. For example, a user may load a suture on the device by placinga loop of suture over the first jaw member. In some variations thesuture holder may be placed along the length of the device to hold ormanage the suture so that it doesn't interfere with the operation of thedevice or get tangled.

FIGS. 5A-5C and 6A-6C illustrate different views of the first and secondjaw members in one variation. For example, in FIG. 5A the first jawmember is shown with the second jaw member retracted proximally. FIG. 6Ashows a top perspective view of the same first jaw member shown in FIG.5A. In FIG. 6A, the first jaw member includes a channel 605 extendingalong the longitudinal length of the first jaw member; this channel mayform part of the suture engagement region. The channel may hold thesuture so that it extends along the midline of the first jaw member onthe underside of the first jaw member. The notches 607, 609 in the firstjaw member near the proximal end extend toward the midline of the firstjaw member and allow the suture to pass from the top of the first jawmember to the bottom and back out, as discussed above. Thus, the suturemay be held close to the elongate body of the device even when the firstjaw is open to various angles.

FIG. 6B illustrates the underside or bottom of the first jaw membershown in FIG. 6A. The suture management region is the entire openingformed at the distal end. This cavity 613 is surrounded by the inside ofthe first jaw member, and (as mentioned above) may act as a limiter tolimit the tip of the tissue penetrator from extending outside of thefirst jaw member.

FIG. 6C shows the same view as in FIG. 6B, but with the second jawmember axially extended distally.

Returning now to FIG. 5B, a side view of the distal end of one variationof a suture passer is shown with the second jaw member extendeddistally. FIG. 5C shows the same view as in FIG. 5B but with the outercannula covering for the elongate member removed, showing the connectionbetween the second jaw member and the pushing/pulling element (rod 505).The pushing/pulling element may be a wire, shaft, tendon, or the like,allowing the second jaw member 503 to be controllably slid distally andproximally. Not visible in FIGS. 5A-6C is the tissue penetrator, whichis fully retracted into the second jaw member in this exemplaryembodiment.

FIG. 7A shows one variation of a tissue penetrator 700 as describedherein. In this example, the tissue penetrator includes a sharp, pointeddistal tip 701 and just proximal to the distal tip is a sutureengagement region configured as a hooked cut-out region 703. Theproximal end of the tissue penetrator includes a coupling region forcoupling the tissue penetrator with a pusher/puller mechanism, such as ashaft, rod, wire, tendon, or the like.

FIG. 8 shows the same perspective view of FIG. 4, but with the tissuepenetrator 805 partially extended across the distal-facing openingformed between the first jaw member 801 and the second jaw member 803. Asuture 808 is looped around the first jaw member 801. Both ends of thesuture pass into the notched region and are held close to the elongatebody, allowing the loop of suture to be held in tension within thesuture engagement region.

FIGS. 9A-9C illustrate the variation of the device described abovepassing a suture from the first jaw member to the second jaw member. InFIG. 9A, the distal end of the second jaw member for the dual deploymentsuture passer has been extended fully. The upper jaw is held at an anglerelative to the elongate body region of the device proximal to the joint(e.g., hinge, bend region, etc.) of the first jaw member. A suture hasbeen loaded into the suture engagement region, and extends along thelength of the midline of the first jaw member. In FIG. 9B, the first jawmember has been moved slightly (decreasing the angle between the firstjaw and the fully extended lower jaw member). This may be typical ofsituations in which tissue is held between the first and second jawmembers. Clamping the tissue to be sutured in this manner allows thetissue to be secured within the jaws, preventing it from movingundesirably, and helping the tissue penetrator to penetrate through thetissue. Further, in FIG. 9B the tissue penetrator has been extended fromthe lower second jaw member across the distal-facing opening, towardsthe first jaw member and the suture retained therein. Once the tissuepenetrator contacts the suture, it may be grabbed or otherwise engagedby the suture engagement member of the tissue penetrator. Thereafter,the suture can be pulled back down with the tissue penetrator as itretracts back into the second jaw member. In this variation, the loop ofsuture is pulled back through the tissue.

Although the variation of the suture passer shown and discussed aboveincludes relatively straight first and second jaw members, otherconfigurations of jaw members are possible. For example, FIGS. 10A and10B illustrate two variations of the upper jaw member. In particular,FIG. 10B shows a variation in which the straight jaw member of the firstjaw member is instead a curved jaw member; the curve may allow a greaterthickness of tissue to be placed between the jaws and may also be usefulfor navigating certain tissue regions, such as the labrum and ACL.

In general, the first jaw member in many of the variations describedherein may be dynamically angled with respect to the elongate body ofthe device. The first jaw member may be connected to and extend from thedistal end of the elongate body, or may be connected to an intermediateregion between the elongate body and the first jaw member. For example,in FIG. 11, a first jaw member is hinged to the elongate body, so thatit can be controllably moved to change the angle between with theelongate body long axis. The first jaw member hinge 1103 thus allows theposition of the first jaw member 1101 to be adjusted (e.g., more openedor closed) as the device is positioned within the body towards a desiredtissue to be sutured. This adjustability may allow the suturing deviceto be inserted further into the space, hence farther from any insertioncannula 1109. This scissoring jaw mechanism, in combination with theabsence of a second (lower) jaw member, which may be retractedproximally, enables the device to surround a target tissue without beingtrapped within the cannula 1109 opening (the jaws don't have to beopened as traditional jaws would be) as it is being positioned.

For example, FIGS. 12A-12E illustrate one variation of the operation ofa dual deployment suturing device in which the first (upper) jaw memberis hinged and the second (lower) jaw member slides axially relative tothe elongate body region proximal to the first jaw member. This designallows the device to surround tissue in difficult to reach areas, whileat the same time protecting nearby tissue from iatrogenic damage. InFIG. 12A a cannula has been placed within the body near the targettissue. Non-target tissue to be avoided is also nearby. For example thenon-target tissue region may be a nerve, an artery, a vein, bone,cartilage, etc. In FIG. 12B, the suturing device is extended from thecannula with the distal end of the first jaw member leading. The firstjaw member may be held in a horizontal position (at an angle of 0°relative to the long axis of the elongate body). In this example, thesecond jaw member is retracted proximally and is therefore kept out ofthe way of the distal end region of the device as it is positioned nearthe target tissue. In FIG. 12C the first jaw member is angled “up” (atan angle of about 30° with respect to the long axis of the elongatebody) allowing the device to maneuver around the potentially sensitivenon-target tissue so that it can be positioned adjacent to the targettissue. All of these maneuvers may be performed with the help ofvisualization, such as arthroscopic visualization. In FIG. 12D, once thefirst jaw member is adjacent to the tissue, the second jaw member may bedistally extended by moving axially from the distal end of the elongatebody, as shown. This motion of the second jaw member may also bereferred to as a telescoping motion, as it is extending out of theproximal region toward the distal end by axially sliding. As the secondjaw member extends distally it surrounds the tissue between the firstand second jaw members, forming a distal-facing opening in which thetarget tissue resides, as shown in FIG. 12E. Thereafter, the tissuepenetrator may be extended between the first and second jaw members,allowing the tissue penetrator to pass the suture from the first to thesecond jaw member. When the suture has been passed and the tissuepenetrator retracted back into the second jaw member, the second jawmember may be retracted back towards the elongate member, proximally,and the entire device withdrawn from the tissue or away from the targettissue. The suture passing through the tissue may then be knotted orotherwise anchored.

FIGS. 13A to 13C illustrate operation of another variation of a suturepasser in which the second jaw member is a side swinging member. In thisvariation the second jaw member extends from the proximal portion (e.g.,behind the first jaw member or the hinge of the first jaw member) to adistal position by a side swinging motion. Although this motion wouldnot be permitted everywhere in the body, there may be some variations inwhich this side swinging motion may be desired.

FIGS. 14A-14C illustrate operation of another variation of a suturepasser having a first jaw member that swings from a proximally locatedposition (e.g., proximal to the upper jaw) to a distal position able toform a distal-facing jaw opening with the second jaw member. In thisvariation the second jaw member swings down (away from the long axis ofthe device) and back up to be positioned distally and opposite the firstjaw member as shown in FIGS. 14B and 14C.

Other variations of motion of the second jaw member are possible,including compound motions that combine more than one of the axialmotion, side-swinging motion and down-swinging motion. For example,FIGS. 15A-15C illustrate a second jaw member having a compound orcomposite motion. In any of these variations, the second jaw membertypically goes from a retracted position in which it is held proximal tofirst jaw member and/or proximal to the distal end of the elongate body,to an extended distal direction.

The position of the first jaw member and the second jaw member may beseparately and/or independently controlled. For example, any of thevariations described herein may include a proximal handle havingcontrols for controlling the activation of the first jaw member, thesecond jaw member, and the tissue penetrator. For example, FIG. 17A isan enlarged view of the handle region of the suture device discussedabove in FIGS. 1-3. In this example, the handle includes a control tocontrol the motion of the first jaw member (which may also be referredto herein as a clamp trigger), a second jaw member control 1605 (orlower jaw handle), and a tissue penetrator control 1607 (or needletrigger). Additional controls may include a lower jaw screw lock to lockthe position of the lower jaw member. The operation of this handlevariation in controlling a dual deployment suture passer is describedbelow with respect to FIGS. 19A-19F.

FIG. 17B illustrates another variation of a handle for a dual deploymentsuture passer. In this variation the handle controls aretriggers/handles. The proximal trigger 1705 is a squeeze handle thatcontrols the angle of the first jaw member relative to the elongatebody. The control and handle are configured with a bias element (spring1707) that tends to keep the first jaw member at an angle with respectto the elongate member; in this example, the angle is about 30° relativeto a line extending distally from the long axis of the elongate bodyregion of the device. A second grip control 1709 controls the extensionof the second (lower) jaw member (not visible in FIG. 17B). In thisvariation a second biasing element (spring) 1711 tends to hold thecontrol so that the second jaw element is retracted proximally and, inthis example, into the elongate member. A third trigger control 1715controls the extension of the tissue penetrator. This control isarranged to include a lock that prevents the control from engaging withthe tissue penetrator until the second jaw member is completelyextended. Further, the control also includes a travel limiter 1721 thatlimits how far the tissue penetrator may be extended from within thesecond jaw element based on how angled the first jaw member is,preventing the tissue penetrator from trying to extend beyond the firstjaw element.

In any of the devices described herein, the controls may be handles ortriggers (as illustrated in FIGS. 17A and 17B) or other controls, suchas dials, buttons, sliders, switches, or the like.

As mentioned above, although many of the suture passer devices(including the dual deployment suture passers described above) limit thetravel of the tissue penetrator to prevent it from extending beyond theopposite jaw member from where it is housed when not extended, in somevariations it may be beneficial to allow the tissue penetrator to extenddistally out of the opposite jaw member, as illustrated in FIGS.16A-16C. In this example the tissue penetrator is deflected within theopposite jaw member and allowed to extend distally out of the oppositejaw member some amount (e.g., less than 5 mm, about 5 mm, less than 4mm, about 4 mm as shown in FIG. 16B, less than 3 mm, about 3 mm, etc.).For example, as shown in FIG. 16A, the tissue penetrator may be housedin the second jaw member and may be deployed across the distal-facingopening formed when the first and second jaw members are extended fullydistally. The tissue penetrator is shown partially extended from thesecond jaw member in FIG. 16A, however it should be understood that thetissue penetrator (including the tip of the tissue penetrator) may befully retraced or retractable into the second jaw member. Also, forconvenience in FIGS. 16A-16C, the jaw members are shown close together,e.g., with only a little space between the first and second jaw members;the jaws may be more opened, for example, by moving the first (upper)jaw member at an angle with respect to the more proximal region of thedevice.

In FIG. 16B the tissue penetrator 1622 extends from within the secondjaw and across the distal-facing opening to pass into an opening on theopposite (first or upper) jaw member. The tip of the needle is pointedin this example, and a side region of the needle proximal to the pointeddistal tip is recessed to form a suture engagement region that ishook-shaped. Extending the needle into and partially out of the firstjaw member as shown in FIG. 16B allows the suture engagement region onthe tissue penetrator to engage the suture held by the first jaw member,as shown. The tissue penetrator in this example extends out of thedistal end of the first jaw member distally (not laterally) and islimited to extending just a finite amount (e.g., less than 4 mm) fromthe distal tip of the first jaw member. In FIG. 16C, the tissuepenetrator is retracted back to the second jaw member, pulling thesuture with it in the suture engagement region.

The variation of the suture passer illustrated in FIGS. 16A-16C in whichthe tip of the tissue penetrator extends distally, has various featuresor advantages including simplifying the coordination between the variousparts. For example, less coordination is required to limit the needlemotion (e.g., stopping it before it crashes into the first or upperjaw). This may allow greater tolerances, and the parts may require lessprecision. Also, extending the tissue penetrator distally may allow for“over travel” of the tissue penetrator and provide for more reliableengagement (hooking) of the suture by the suture engagement region. Thedistal end of the first jaw member may include sufficient space for thetissue penetrator to over-travel the suture so that the hook (sutureengagement feature) on the tissue penetrator can grab the suture on itsway back to the lower (second) jaw member. With this variation, theheight of the first jaw member can be compressed sizably, and theover-travel necessary to pick up the suture is directed in a manner thatdoesn't require additional height. Further, the additional over-travelopportunity offered by this configuration may allow use of a symmetricdistal tip region for the suture penetrator, e.g., having a point in themiddle of the tissue penetrator distal tip region. Asymmetric tissuepenetrators may also be used (e.g., having a point on one side of thetissue penetrator). Other examples of suture passers (including dualdeployment suture passers) having tissue penetrators configured toextend beyond the distal end of a jaw member are described andillustrated below, including in FIGS. 32A to 55DD.

FIGS. 18A-18C illustrate another variation of a suture passer. In FIG.18A, the second jaw member is not retracted proximally, and the firstand second jaw members are clamped together. The first jaw member may beopened as shown in FIG. 18B, and the tissue penetrator may be extendedacross the distal-facing opening, as shown in FIG. 18C.

Methods of Use

In general, the devices described herein may be used to suture anyappropriate tissue. These devices are particularly well suited forpassing a suture in a minimally invasive procedure to reach difficult toaccess regions. Examples of the use of these devices are provided below,and illustrated in FIGS. 19A to 31F.

The general operation of one variation of a dual deployment suturepasser is illustrated in FIGS. 19A-19F. The clamping/sliding suturepasser illustrated in FIG. 19A includes a handle such as the one shownin FIG. 17A, above. Before use, a suture may be loaded on the first jawmember of the device. For example, a loop of suture may be loaded ontothe first jaw member. The free ends of the suture may be coupled to asuture control element such as a tensioning screw, as shown in FIG. 19A.For example, the two free ends may be cinched onto a tensioner screw.The suture passer may be loaded outside of the body by the user, or itmay be pre-loaded. Once loaded, the suture passer may be inserted intothe body near the target tissue. For example, the device may be insertedinto the body through a cannula. As shown in FIG. 19A, the second(lower) jaw member may be fully retracted proximally, and the upper jawmay be clamped down fully so that it is in-line with (straight) relativeto the elongate member; the first jaw member may be locked in thisposition for insertion, or it may be moved or dynamically adjusted as itis inserted.

Thereafter, the device may be positioned relative to the target tissue.For example, the first jaw member may be positioned adjacent to thetarget tissue. As shown in FIG. 19B, the device may then be positionedand the clamp trigger adjusted or released.

Once the tissue is adjacent to the first jaw member, the second jawmember may be extended to surround a target tissue, as shown in FIG.19C. In this example, the control for the second jaw member (the lowerjaw lock) may be actuated to slide the lower jaw member distally,forming the distal-facing opening, and surrounding (at least partially)the target tissue to be sutured. As shown in FIG. 19C, this may beachieved by sliding in and locking the lower jaw with the lower jawhandle by releasing the lower jaw screw lock and sliding the lower jawinto position. The lower (second) jaw may then be locked in a fullyextended position.

The upper (first) jaw member may be adjusted to clamp or hold the targettissue securely between the upper and lower (first and second) jawmembers, as illustrated in FIG. 19D. Thereafter, the tissue penetratormay be actuated (e.g., by squeezing the needle trigger) to extend fromwithin the lower jaw member, through the tissue between the first andsecond lower jaw members, and across to the upper jaw. To engage asuture held within the suture engagement region in the upper jaw. Thetissue penetrator may then pick up the suture from the upper jaw andpull it back down through the tissue, as shown in FIGS. 19D and 19E.

Once the suture has been hooked, the tissue penetrator may be retracedback into the second jaw member (in this example), as shown in FIG. 19F,and the lower jaw member may be retraced proximally, in the reverse tothe process described above, so that the suture passer, which havingpassed the suture successfully, may be withdrawn from the patient.

FIGS. 20A-20B show a generic version of a dual deployment suture passer.FIG. 20A shows a suture passer having a second jaw member in a retractedstate; FIG. 20B shows the same suture passer with the lower jaw in anextended state. This generic schematic of a dual deployment (e.g.,clamping/sliding) suture passer may be used to illustrate operation ofthe device in different tissues.

Any of the devices described herein may be used to suture and treat atorn meniscus of the knee. For example, in FIGS. 25A-25H a torn meniscus2503 is repaired using the device as discussed above. In FIG. 25A thesuture passer 2505 is inserted into the knee with just the first jawmember extended. The jaw member can easily fit between the femur andtibia of the knee to approach the meniscus 2501. The first jaw membercan then be slid between the superior surface of the meniscus and thefemur (as shown in FIG. 25B). The angle of the first jaw member may bedynamically adjusted as the suture passer is inserted to best match thetissue. This procedure may be observed arthroscopically. Thereafter, thesecond jaw member 2507 may be advanced under the meniscus between theinferior surface of the meniscus and the tibia, until the second jawmember is fully extend and the target tissue, including the meniscaltear 2503 is surrounded within the jaws of the device as shown in FIG.25C.

The meniscus tissue may then be clamped between the first and second jawmembers, and the tissue penetrator may be extended across the tissue, asshown in FIG. 25D. The arrow indicates the direction of the tissuepenetrator from the lower (second) jaw member, through the meniscus andinto the upper (first) jaw member. The tissue penetrator may then engagethe suture held in the first jaw member. The tissue penetrator isprevented (e.g., by a limiter) from extending beyond the upper jawmember, and may then be retracted, as shown in FIG. 25E, by withdrawingthe tissue penetrator back down through the meniscus and into the lower(second) jaw member, pulling the suture loop with it. In FIG. 25F, thesuture has been completely drawn through the meniscus and the tissuepenetrator completely retracted. Thereafter the lower jaw member mayalso be withdrawn by axially retracting it proximally, as shown in FIG.25G. The suture passer may then be withdrawn from the meniscus, as shownin FIG. 25H. The looped suture may be pulled so that one free end of thesuture is pulled through the meniscus (leaving a single suture length,rather than a loop of suture passing though the meniscus). The suturemay then be knotted.

FIGS. 26A-26H illustrate another variation of a method of using thesuture passer devices described herein to treat a patient. In thisexample, the method is used to treat a Bankart tear, an anteriorinferior (or posterior inferior) labral tear. FIG. 26A illustrates thelabral tear. In FIG. 26B the suture passer is inserted into the shoulderand the first jaw member is positioned (by dynamically adjusting theangle of the first jaw member) adjacent to the torn tissue, as shown inFIG. 26C. In FIG. 26C, the first jaw member is placed over the labrumand the anterior-inferior capsule. The lower (second) jaw member maythen be axially extended so that the jaws now encompass thelabro-capsular region, as shown in FIG. 26D. The first jaw may beadjusted to clamp the target tissue securely between the jaws and thetissue penetrator may be extended to pass a suture between the jaws, asshown in FIG. 26E. The lower (second) jaw member may then be retracted(FIG. 26F), and the device may be removed, as shown in FIG. 26G. A knotor tie may then be slid over the suture ends to tie off the suture asshown in FIG. 26H.

The suture passer devices and methods describe herein may also be usedto repair a hip labrum, as illustrated in FIGS. 27A-27G. In FIG.27A-27B, the hip labrum may be approached by the suture passer havingthe second jaw member retracted and the first jaw member extendeddistally. The angle of the first jaw member may be dynamically adjustedto help pass the suture passer near the labrum to be sutured, as shownin FIG. 27C. In FIG. 27D, the second jaw member may be axially extendedfrom a proximal position to slide beneath the labrum and form adistal-facing opening so that the first and second jaw members surroundthe labrum tissue as shown in FIG. 27D. In FIG. 27E the tissuepenetrator may then be extended across the distal-facing opening andthrough the tissue to grab (or in some variations drop off) a suture inthe suture engagement region of the opposite jaw member. The tissuepenetrator can then be retracted, and the second jaw member can also beretracted proximally, as shown in FIG. 27F. Finally, the device can bewithdrawn from the tissue, as shown in FIG. 27G.

In any of the methods described herein the device may be controlled fromthe proximal end by a handle such as those illustrated above (e.g.,FIGS. 17A and 17B). The device may be controlled using a single hand.

FIGS. 28, 29, 30A-30F and 31A-31F illustrate the use of a suture passerdevice such as the one illustrate herein to repair spinal tissue. Forexample, FIG. 28 shows a normal disc of a spine (a schematicillustration of a section through the spine is shown). In contrast, FIG.29 shows a herniated disc. Traditionally this region has been difficultto access and thus difficult to suture. One variation of a device asdescribed herein may be used to suture the disk annulus. For example,FIG. 30A shows a suture passer as described herein approaching theherniated disc. The angle of the first jaw member may be dynamicallyadjusted to help position the first jaw member adjacent to the tissue(e.g., the annulus) to be sutured. Once in position, as shown in FIG.30B, the second jaw member may be extended so that the tissue to betreated is between the jaws, as shown in FIG. 30C. Thereafter the tissuepenetrator may be extended across the jaws and through the tissue eitherto push a suture to the opposite side (FIG. 30D), or in some variations,to pull the suture from the opposite side back through the tissue. Thesecond jaw member may then be retracted (FIG. 30E) and the entire devicewithdrawn from the disc region, as shown in FIG. 30F, leaving the suturebehind.

In general, a suture may be passed from the first jaw member to thesecond jaw member or vice versa. Further, the tissue penetrator may beconfigured to push the suture through the tissue or it may be configuredto pull the suture through the tissue; the suture engagement region onthe opposite side of the jaw from that housing the tissue penetrator maybe adapted for either receiving a suture (e.g., having a clamping regionor gripping region, a hook, or the like) or for passing on a suture(e.g., holding the suture in position where it may be grabbed by thetissue penetrator). In addition, the tissue penetrator may be in eitherthe second jaw member (as primarily illustrated above) or it may be inthe first jaw member; the appropriate engagement region may be presenton the opposite jaw as well.

FIGS. 31A-31F show another view of the method for suturing an annulus ofa disc of a spine. For example, in FIGS. 31A to 31C, the suture passerincluding an extended first jaw member approaches the torn tissue to besutured. In FIG. 31D the second jaw member is axially extended on theopposite side of the tissue to be sutured, and the tissue penetrator isextended to pass the suture through the tissue. In FIG. 31 the tissuepenetrator has been retracted and the second jaw member has also beenretracted, so that the suturing device may be withdrawn while pullingthe suture through the tissue, as shown in FIG. 31F.

Sigmoidal Tissue Penetrators

As discussed above, in reference to FIGS. 16A-16C, any of the devicesdescribed herein may be configured so that the tissue penetrator mayextend distally from the distal end of one of the jaw members. Thus, insome variations, a tissue penetrator includes a mouth that opens in adistal-facing direction. The mouth is formed from a first jaw (e.g.,upper jaw) and a second jaw (e.g., lower jaw); the tissue penetrator mayextend between the first and second jaw in an approximately sigmoidalpathway. This is illustrated in FIGS. 32A-32C.

FIGS. 32A-32C show a schematic of one variation of a tissue penetratorhaving a distal-facing mouth 3201. The tissue suture passer has beenmade semi-transparent to show the tissue penetrator 3203 within thelower jaw member in FIG. 32A. In this example, the suture passer isconfigured so that the tissue penetrator may be extended distally first(in FIG. 32A) through the lower jaw member 3205 until it is deflectedout of the lower jaw and across the distal facing mouth 3201. In thisexample, the lower jaw includes a deflector 3213 that redirects thetissue penetrator out of the lower jaw and towards the upper jaw, asshown in FIG. 32B. The tissue penetrator may pass through any tissueheld within the open mouth 3201, and eventually meet the upper jawmember 3207. Once within the upper jaw member 3207, the tissuepenetrator may then be deflected so that it extends distally within theupper jaw member. As shown in FIG. 32C, the tissue penetrator 3203 maybe deflected distally by an internal deflector 3209 within the upper jawmember 3207. The tissue penetrator 3203 may extend distally out of adistal opening 3211 at the distal end of the upper jaw member 3207.

Although many of the suture passer variations configured for sigmoidalmovement of the tissue penetrator, in which the tissue penetratorextends distally from a jaw member, may be configured as dual deploymentsuture passers (e.g., in which the two jaw members move independentlywith different types of motion), suture passers with fixed jaws orsuture passers in which only one jaw moves relative to the suture passermay be used. For example, FIGS. 33A-33F show three different variationsof suture passers having a distally extending tissue penetrator thattravels in an approximately sigmoidal path.

For example, in FIG. 33A the upper and lower (first and second) jawsforming the distal-facing mouth of the suture passer are both movable,as described above for the dual deployment configuration. The tissuepenetrator 3304 is shown extending from the lower jaw member 3303,across the distal-facing opening, and into the upper jaw member 3306,where it then extends distally slightly beyond the distal end of theupper jaw 3306. The suture passer of FIG. 33A is also shown in FIG. 33B,illustrating the movement of the upper and lower jaw members. Asindicated in FIG. 33B, the upper jaw 3306 can pivot 3315 around a hingepoint 3311 at the distal end region of the elongate member 3308. Thelower jaw member 3303 can move axially (proximally and distally) 3317relative to the elongate member 3308.

In FIGS. 33C and 33D, only one of the jaw members (the upper jaw member)may move; the opposite jaw member is fixed. In FIG. 33C, similar to FIG.33A, the tissue penetrator extends distally from the upper jaw member3306 out of a distal opening (not shown), along a sigmoidal path. Asshown in FIG. 33D, the upper jaw includes a hinge point 3311 so that itcan be controllable pivoted 3327 (using a proximal control) to form anangle with respect to the distal end region of the elongate shaft.

In FIGS. 33E and 33F, the upper jaw is shown as fixed (e.g., in apre-formed bend or angle relative to the distal end of the elongatemember) and the lower jaw may be moved axially distally/proximally 3337.

The path taken by the tissue penetrator may be approximately sigmoidal,as illustrated in FIGS. 34A-34E. FIG. 34A illustrates the differentpaths for a tissue penetrator in a suture passer having an upper jawmember that pivots. In any of the angled positions shown the suturepasser may take an approximately sigmoidal path. FIGS. 34B-34Eillustrate different sigmoidal paths for the tissue penetrator. Ingeneral the term sigmoidal path should be understood to be approximatelysigmoidal when viewed in profile, as shown in FIGS. 34B-34E. In theseexamples the distal end of the tissue penetrator may extend distally atapproximately the same angle as the upper jaw member (as indicated bythe arrows to the left of each of FIGS. 34B-34E), rather thanhorizontally and parallel to the lower jaw member, as in a completelysigmoidal path.

FIGS. 35A and 35B show one variation of a tissue penetrator from a top(FIG. 35A) and side (FIG. 35B) view. The distal end region of the tissuepenetrator includes a suture retainer region 3505 configured as a hook.

In general, the needle width may be between 0.1″ and 0.02″. For example,in some variations the needle is approximately 0.058″ in width. Theneedle may be relatively thin, e.g., having a thickness between about0.02″ and about 0.005″. For example, in some variations the needle isapproximately 0.0115″ thick. In some variations the needle has athickness of about 0.008″. In general, the needles described herein havesufficient column strength to push through the tissue, and can be bentor deflected with sufficiently low force to accomplish the sigmoidalbend described herein; these needles may also have sufficient fatiguelife to withstand multiple (e.g., 5×, 10×, 20×) extensions andwithdrawals between the upper and lower jaw members and out of thedistal opening in the upper jaw member.

FIGS. 36A-36E illustrate another variation of a dual deployment suturepasser having a tissue penetrator that is configured to travel in asigmoidal path and extend distally from a distal opening in the distalend of the device. In this variation, the upper jaw may pivot and thelower jaw extends distally/proximally in the axial direction. A suture(not shown) may be loaded in the upper jaw so that it may be captured bythe suture passer and pulled back through the tissue down to the second(lower) jaw member, as described in FIGS. 16A-16C, above. In FIG. 36A,the suture passer is shown in an undeployed state, with the pivotingupper jaw member 3601 at a 45° angle relative to the long axis of theelongate body 3603. As discussed above, in practice the device may beeasily inserted into the tissue and adjacent to the target tissue, andthe angle of the upper jaw member may be adjusted to help position thedevice. In this variation the upper jaw is relatively flat (e.g., has anarrow profile).

In FIG. 36B, the lower jaw 3605 has been extended distally from thedistal end of the elongate body. In FIG. 36C, the upper jaw member hasbeen pivoted downward (“clamping” down) so that the angle relative tothe long axis of the elongate body is approximately 30°, and the tissuepenetrator 3607 is being extended from the lower jaw 3605 and across thedistal-facing mouth to the upper jaw, as also shown in FIG. 36D. Thetissue penetrator finally extends distally from the opening 3611 at thedistal end of the upper jaw 3601 as shown in FIG. 36E.

FIGS. 37A and 37B show side and top perspective views, respectively, ofone variation of such an upper jaw member. This variation is similar tothat shown in FIGS. 36A-36E, and allows loading of a suture on the upperjaw member as previously shown in FIG. 16A-16C. In FIGS. 37A and 37B,the upper jaw member includes a deflection surface 3703 and a distalopening 3705 out of which the tissue penetrator (not shown) may exitdistally. The upper jaw shown in FIGS. 37A to 37B also includes a sutureloading region 3711 into which one or more sutures may be threadedand/or preloaded so that they may be engaged by the tissue penetratorand pulled from the upper jaw to the lower jaw. In this variation thesuture loading region is a channel that is adjacent to the deflectionsurface 3703. A tensioning element (not shown) may be used to hold thesuture in the loading region. The tensioning element may be on the upperjaw member, or it may be located more proximally, including on theproximal handle. The tensioning element may be configured to pinch orbind the suture to hold it in position (and in tension) so that it canbe engaged by the suture retainer region on the tissue penetrator.

FIGS. 38A and 38B illustrate another variation of the upper jaw memberof a suture passer, in which the upper jaw member includes a suturestripper for removing (stripping) the suture off of the suture retainerregion of the tissue penetrator and holding the suture (or a loop orbight of suture) in the upper jaw. In FIG. 38A, the upper jaw member3801 includes a deflector region 3803 that is formed, in part, from thesuture stripper 3805. The stripper is formed of a flexible material(e.g., a metal, polymer, or other material, including shape memoryalloys) that can be resiliently deflected to allow the tissue penetratorto pass and extend distally from the distal opening 3809, whilestripping the suture off of the tissue penetrator and holding the suturein the upper jaw. This is described in more detail below. In FIG. 38A,the suture stripper is configured as a leaf-spring structure that issecured to the upper jaw member at the proximal end and the opposite endis free and held in tension against a distal surface of distal openingat the distal end of the device; the tissue penetrator may push againstthe stripper and past it, forcing a suture held in the tissuepenetrator's retainer region against the stripper. As the tissuepenetrator is withdrawn, the suture may be pinched against the stripperand the upper jaw, holding it in place while allowing the tissuepenetrator to be withdrawn. In some variations the end of the stripperand/or the distal opening includes an edge (e.g., having serrations,teeth, etc.) to hold the suture as the tissue penetrator is withdrawn.

FIGS. 39A-39C illustrate one variation of a suture passer having atissue penetrator that extends distally from a distal opening in theupper jaw. The tissue penetrator travels in a sigmoidal path from thelower to upper jaw. In this variation, two lengths of a suture(including two lengths of the same suture, e.g., two ends of the samesuture) can be loaded into the lower jaw and sequentially passed fromthe lower jaw, through different regions of the tissue and retained inthe upper jaw, to pass a loop of suture through the tissue. The suturepasser show in FIGS. 39A-39C is also configured so that the upper jawmember can pivot to assume a different angle relative to the elongatebody of the device, and the lower jaw member is axially extendabledistally from the distal end of the elongate member to form adistal-facing mouth with the upper jaw member. The proximal handleincludes a plurality of controls for controlling the pivoting of theupper jaw member, the axial sliding of the lower jaw member, and theextension/retraction of the tissue penetrator from the lower jaw member.

FIG. 39B shows the device of FIG. 39A with the outer housing of theproximal handle 3901 removed, revealing some of the connections betweenthe controls and the device. In FIG. 39B, the distal most control 3905,the proximal handle is configured as a trigger or lever that controlsthe motion of the upper jaw member (“upper jaw control”). The upper jawcontrol may be pulled to reduce the angle of the upper jaw relative tothe long axis of the elongate member 3907. In this variation the upperjaw control is pinned and allowed to drive a tendon in the elongatemember distally when compressed to drive the upper jaw down (reducingthe angle between the upper jaw and the long axis of the elongatemember). This pivoting motion may also be referred to as scissoring(scissoring motion).

A distal control 3913 is also configured as a lever or trigger, and maybe squeezed or otherwise actuated to extend and/or retract the lower jawto form a distal-facing mouth with the upper jaw, as shown in FIGS.39A-39B. In some variations the control is further configured to controldeployment of the tissue penetrator in the sigmoidal path. For example,in some variations squeezing the distal control after completelyextending the lower jaw may deploy the tissue penetrator from the lowerto the upper jaw so that the distal end of the tissue penetrator extendsout of the upper jaw. As it extends between the upper and lower jaw, thetissue penetrator may carry a first length (bight) of suture through thetissue. Upon reaching the opposite jaw member, the suture may be removedfrom the tissue penetrator and held (e.g., by a stripper) in the upperjaw. Upon release of the distal control, the tissue penetrator maywithdraw back into the lower jaw. Actuating (e.g., squeezing) the distalcontrol 3913 again may result in the extending the tissue penetrator(along with any second length of suture) back through the tissue fromthe lower jaw to the upper jaw, where the second length of suture can beretained. Alternately, in some variations, the controls (e.g., tocontrol motion of the upper and/or lower jaw) may be separate from eachother, and/or from extending/withdrawing the tissue penetrator.Additional controls may also be included in the proximal handle, includea suture loading control (e.g., switch, toggle, etc.) for loading and/ortensioning the suture within the lower jaw member.

FIGS. 40A-40D show an enlarged view of the distal end of the device ofFIGS. 39A-39C. For example, in FIGS. 40A and 40B the upper jaw 4003 isthin and slightly radiused (e.g., curved), and is hinged to the elongateshaft region of the device. The upper jaw is also connected to a control(handle, etc.) on the proximal handle by a push/pull member (tendon,wire, rod, etc.), allowing adjustment of the angle of the upper jawmember relative to the elongate member.

In FIG. 40C, the upper and lower jaw members have been removed from thedistal end of the device shown in FIG. 40B, revealing the tissuepenetrator 4007 within the lower jaw and the stripper 4009 in the upperjaw. FIG. 40D shows the distal end of the device of FIG. 40B after thetissue penetrator has been extended across the distal-facing mouth.FIGS. 42A and 42B illustrate one variation of an upper jaw region havinga suture stripper. In FIG. 42A, the suture stripper is visible from thedistal opening at the distal end of the jaw member. In this example, thestripper includes a stripper plate 4203 with a sawtooth edge 4205. Thejaw member also includes a receiver region for the stripper plate havinga sawtooth edge 4207.

FIGS. 41A-41C show greater detail on one variation of a suture stripperthat may be used. This variation is the same as the variation shown inFIGS. 42A and 42B. Although the examples provided herein show the suturestripper in the upper jaw member, in some variations a suture strippermay be present on the lower jaw member (e.g., where the tissuepenetrator is configured to pass a length of suture from the upper jawto the lower jaw). In FIG. 41A, the stripper includes a flexible plate4101 that is fixed at the proximal end (e.g. to the upper jaw member),and pressed against a receiving plate 4103 at the distal end 4105. Insome variations the receiver is not a separate receiving plate, butmerely a region of the jaw member. Either or both the suture stripperplate 4101 and the receiver 4103 may include an edge that is adapted tocatch the suture. In FIGS. 41A-41C, both the plate 4101 and receiver4103 include edges having teeth 4105 and 4107. In this example the teethare saw-tooth structures that are adjacent (or abutting) in the upperjaw member. The tissue penetrator may pass between the plate 4101 andthe receiver 4103 by deflecting the plate 4101; as the end of the tissuepenetrator passes the edges 4105 and 4107, a length of suture held bythe tissue penetrator may be caught by the stripper and held between theplate and receiver as the tissue penetrator is withdrawn. This isillustrated in FIGS. 43A-43E.

For example, FIG. 43A shows a cross-section through a mount that mimicsthe stripper device and upper jaw member shown in FIGS. 42A and 42B. InFIG. 43A, the stripper 4301 is configured as a leaf-spring structurethat is fixed at the proximal end 4303 and can be displaced by thetissue penetrator at the distal end. In FIG. 43B a tissue penetrator4307 holding a length (loop or bight) of suture 4309 is advanceddistally, deflecting off of the bottom surface of the stripper 4301; thetissue penetrator 4307 causes the stripper to deflect upwards as thetissue penetrator 4307 is passed out of the distal end of the jawmember, as shown in FIG. 43C. As the tissue penetrator 4307 iswithdrawn, as shown in FIG. 43D, the length of suture 4309 (which haspassed beyond the distal end/edge of the stripper) is pinched betweenthe stripper and the receiver (e.g., the lower surface of the jawmember). Once the tissue penetrator 4307 has been completely withdrawn,the suture 4309 remains held by the stripper in the jaw member.

In practice, a suture passer having a distally-extending tissuepenetrator may be used to repair a tissue such as the meniscus of theknee. FIGS. 44A-44F illustrate one method of repairing a torn meniscususing a suture passer such as the one shown above in FIGS. 39A-39C.

The devices described herein may be used to pass a loop of suture andspecifically, may be used to form a vertical or horizontal stitch torepair tissue. When repairing the meniscus, a vertical stitch typicallyprovides the strongest repair with the least amount of displacementrelative to horizontal stitches or other “all-inside” approaches. Thedevices and methods described herein may also be referred to as“all-inside” devices and meniscal repair techniques allow the meniscusto be sutured directly. The suture passers described herein may place afully-circumferential, vertical stitch around meniscal tears. Thisstitch may provide uniform compression along the entire height of themeniscus and maintain coaptation of the tear at both the inferior andsuperior meniscal surfaces. Further, because of the jaw and needleconfiguration, the distal extending tissue penetrator does not penetratethe capsule wall, reducing or eliminating risk to posteriorneurovascular structures. These features may allow a greater healingresponse due to complete tissue coaptation along the entire substance ofthe tear, improved clinical outcomes due to the greater healing responseand to the anatomic reduction and fixation of the meniscus tear, mayavoid scalloping or puckering of the meniscus, and may result in lessextrusion or peripheralization of the meniscus caused by over-tensioningof suture or hybrid tensioners to the capsule. These devices can also beused to treat radial, horizontal, flap, and other complex tears inaddition to longitudinal tears.

In some variations, the suture passer devices described herein can befired blindly where arthroscopy camera access is poor, as kneestructures are protected from the needle path.

Returning now to FIGS. 39A-39C, as mentioned above, the device (e.g., inFIG. 39C) has a scissoring upper jaw that is curved (radiused). Thiscurve may be configured to follow the radius of the femoral condyle. Thelower jaw in this example is straight. The lower jaw may be recessedinto the shaft, and may slide proximal-to-distal in order to slide underthe meniscus along the tibial plateau after the upper jaw is in placealong the superior surface of the meniscus. The lower jaw contains aflexible needle, which moves vertically from the lower to upper jaw.

FIGS. 44A-44F illustrate one method of using a suture passer asillustrated in FIGS. 39A-39C to repair a torn meniscus. As mentioned,the upper jaw of the suture passer may be positioned between thesuperior surface of the meniscus and the femoral condyle, as shown inFIG. 44A. The thin and slightly curved upper jaw follows the curve ofthe femoral condyle. The lower jaw is retracted within the elongatebody, and has been loaded with two lengths of suture (from end regionsof the same suture).

In FIG. 44B, the lower arm is initially retracted; after the upper armis positioned adjacent to the torn region to be sutured, the lower jawis extended underneath the meniscus, as shown in FIG. 44C. The slidinglower jaw may more easily accommodate the spatial constraints of theknee than a fixed or scissoring lower jaw. As described above, the lowerjaw member in this exemplary device houses a flexible tissue penetrator(e.g., needle) that can be advanced through the meniscus to deliversuture bights from the lower jaw to the upper jaw. Once the device is inposition distal to a longitudinal tear or adjacent to a radial tear, thetissue penetrator is advanced from the lower arm to the upper arm. Thetissue penetrator pulls one end of the suture strand from the lower jawto the upper jaw, where it is retained. The tissue penetrator does notpass through the upper jaw, so the femoral condyle remains protected;instead the tissue penetrator extends from a distal opening in the upperjaw, as shown in FIG. 44D. The tissue penetrator is withdrawn into thelower jaw where it engages the opposite end of the suture strand. Thedevice is then repositioned for the second bight, either proximal of alongitudinal tear (see FIG. 44E) or to the other side of a radial tear(not shown in the example). Once in position, the tissue penetrator isadvanced to deposit the remaining suture bight in the upper jaw, asshown in FIG. 44E.

The tissue penetrator can then be brought back into the lower jaw, thelower jaw retracted, and the device may be withdrawn from the knee,leaving a suture loop surrounding the tear, as shown in FIG. 44F, withboth ends exiting on the femoral side. A surgeon may then tie andadvance a sliding knot (or individual throws) percutaneously, and theloose ends cut, as shown in FIG. 44G. Since both suture-ends may beretrieved through the same track, a cannula is not required to preventtissue bridging. This may result in a fully-circumferential, verticalstitch around the tear, as shown in FIG. 44G. This vertical stitchcompletely surrounds the meniscal tear, bringing the superior andinferior margins of the tear in apposition along with the meniscal areain between. FIG. 45A shows a perspective view of a portion of a meniscusrepaired in this manner. FIGS. 45B and 45C illustrate how the device andmethods described above may also be used to suture more complex meniscaltears, including those having a radial tear.

FIGS. 46A-46L illustrate another example of a method for suturing a tornmeniscus by passing a loop of meniscus. As just described, the exemplarydevice shown in FIGS. 39A-39C may be used or other variations of thesuture passer devices described herein may be used to suture a tornmeniscus. In this example, two regions of a suture are initially loadedinto the suture passer in the lower jaw. For example, the first lengthof suture may be loaded into the tissue penetrator and a second lengthof suture may be held in a holding region of the lower jaw; the lowerjaw may be configured so that once the first length of suture has beenpassed into the upper jaw member and the tissue penetrator has beenretracted, the second length of suture may be loaded into the tissuepenetrator for passing through the tissue. In FIG. 46A, the ends of thesuture are shown loaded into the lower jaw. In FIG. 46B and subsequentFIGS. 46C-46K, the upper jaw has been removed from the device shown inFIG. 46A to show the deflecting surface and suture stripper (a sheet ofmetal) in the upper jaw. In FIG. 46C, the tissue penetrator may then beextended from the lower jaw, carrying a length of suture, and pushedthrough the meniscus towards the upper jaw. The suture passer may thenenter into the upper jaw and be deflected by the deflector region withinthe upper jaw so that it extends distally out of the upper jaw member,as shown in FIG. 46D. In this example, as the tissue penetrator pushesup into the upper jaw it pushes the stripper out of the way, allowingthe suture to advance beyond the end of the stripper. In FIG. 46E,retracting the tissue penetrator leaves the suture held by the stripperin the upper jaw. The stripper places a downward force on the tissuepenetrator as it retracts, this force strips the suture off of thetissue penetrator and then pins the suture length in the upper jaw.

As shown in FIG. 46F, the device may then be repositioned to fire asecond time. The device is moved to the second location. Moving thedevice does not dislodge the suture from the upper jaw, as it is securedby the stripper. Retracting the tissue penetrator into the lower jaw maycause the second end of the suture to be loaded into the tissuepenetrator, as shown in FIG. 46G.

The tissue penetrator can then be extended back across the tissue fromthe second position on the opposite side of the meniscal tear, as shownin FIG. 46H. The tissue penetrator carries the second length of suturewith it to the upper jaw, and past the stripper again, as shown in FIG.46I. As before, withdrawing the tissue penetrator after extending it outof the distal end of the upper jaw so that the second length of sutureextends beyond the stripper results in the stripper retaining the secondlength of suture along with the first length of suture, as shown in FIG.46J. The device may then be retracted with both sutures pinned in theupper jaw, as shown in FIG. 46K. The device may be fully retraced, andthe ends of the suture tied, as shown in FIG. 46 L.

As mentioned above, in some variations the suture passer may be loaded(including preloading or manually loaded) with two or more lengths ofsuture (e.g., two loops or bights of suture) than may be passedsequentially. FIGS. 47A-47E illustrate one variation of a lower jaw andtissue penetrator that are configured to be used as part of a suturepasser that can hold and pass two lengths of suture. In FIG. 47A, a jawmember (e.g., lower jaw member) that has a suture loading region 4703adapted to hold a second length of suture while the first length ofsuture is held in a suture retainer region 4705 in the tissue penetrator4701. The jaw member shown in FIG. 47A is not yet loaded with a suture,and includes a central channel 4711 into which the suture may be fed toload the device. The tissue penetrator 4701 is held within the jaw, andis configured to slide axially distally/proximally and can exit the jawmember though a deflecting exit 4715 that directs the tissue penetratoracross an opening formed between the jaw members. FIGS. 47B-47Eillustrate loading of a pair of suture loops into the tissue penetratorand suture loading region 4703. For example, in FIG. 47B, the firstsuture loop 4709 has been passed into the central channel 4711 of thejaw member. This first loop of suture 4709 passes though the sutureloading region 4703 of the jaw member and into the suture retainer orholder region 4705 in the tissue penetrator, as shown in FIG. 47C. Thismay be achieved by positioning the tissue penetrator at a particularregion within the jaw member so that the suture retainer region 4705 iscontinuous with the edge (which may be curved) of the suture loadingregion 4703 so that the suture passes into the suture retainer region ofthe tissue penetrator. A second loop of suture 4708 may then be loadedby again passing the loop over a portion of the jaw member and into thecentral channel 4711. The tissue penetrator may be moved distally orproximally to make room for the second suture loop within the sutureloading region 4703 without interfering with the suture already in thetissue penetrator, as shown in FIG. 47D. Once loaded, the tissuepenetrator may be advanced slightly distally to secure the two sutureloops within the lower jaw, as shown in FIG. 47E. After the first lengthof suture has been passed to the opposite jaw and held there, the tissuepenetrator may then be extended back into jaw member and loaded with thesecond loop of suture, similar to FIG. 47C.

In some variations, the devices described herein may include one or moresuture management features such as suture tensioners, suture cleats,suture clamps, suture channels, and/or other structures that guide,hold, apply tension, and release the suture. These suture managementfeatures may be generically referred to herein as suture cleats.

A suture management feature such as a cleat and/or tensioner may be usedto hold one or more lengths of suture, and may generally aid inpreventing the suture from dropping off of the device and/or becomingtangled. A suture management feature may also help in automaticallyloading a length of suture in a tissue penetrator, as described above inreference to FIGS. 47A-47E. A suture management feature may maintainand/or control the tension on the suture as the device is operated. Forexample, a suture cleat may be biased (e.g., spring loaded) to maintaina relatively constant tension on the suture during operation, or may beused with a tensioning member (such as a tension aim or pin). Asmentioned, a suture management feature such as a cleat may include aprojection, pin, clamp, tensioner or other structure that holds thesuture (or multiple lengths of suture). Further, in some variations asuture management feature such as a cleat may be releasable, eithermanually or automatically, so that when a suture or multiple lengths ofsuture are secured by the cleat the suture(s) may be released from thecleat by triggering a cleat release.

As used herein, a suture cleat may include an opening into which thesuture may be held. For example, a suture cleat may include a projectionto which a length of suture may be secured. The cleat may hold thelength of suture by clamping the suture or by providing a typicallywedge-shaped opening into which the length of suture may be captured. Insome, but not all, variations the suture may be wrapped around thecleat. In some variation, the cleat may actively, e.g., by spring orbiasing member, pinch the suture(s) between one or more surfaces tosecure the suture(s). A suture may be removed from the cleat manually(e.g., by manually pulling the suture out of the cleat) orautomatically. For example, a cleat may include a pushing member thatpushes the suture out of the cleat. In some variations a projectingportion of the cleat may be configured to retract, e.g., into the jawmember, releasing any suture held therein. In some variations, aclamping portion of the cleat may be configured to release or relax anyclamping force holding the cleat. Release of a length of suture from thecleat may be triggered by an actuation mechanism including a mechanicalmechanism (e.g., lever, toggle, cam, etc.) or electrical/magneticmechanism (e.g., solenoid, motor, magnetic catch, etc.). In somevariations the cleat may be triggered to release a length of sutureduring a particular step in the operation of the suture passer. Forexample, the suture may be released from the cleat when the tissuepenetrator is retracted for reloading with a second bight of suture; thesuture cleat may release the suture so that a bight of suture can betransferred from a suture loading region in a jaw into a tissuepenetrator.

Thus, in variations in which multiple bights of suture are loaded in tothe device, a suture management feature may be used to hold and/ortension a second length of suture within the lower jaw member so that itmay engage with the tissue penetrator after the first loop of suture hasbeen passed. For example, FIG. 59A shows a distal portion of a lower jawmember 5901 and tissue penetrator 5903 into which two loops of a suturehave been loaded. A first loop 5905 has been loaded into the tissuepenetrator, and a second loop 5909 has been loaded into a suture loadingregion of the jaw, as described in FIGS. 47A-47E. The ends 5915, 5917are loose, as is the length of suture between the two bights 5913. Insome instances it may be beneficial to secure the free ends of the bight5909 that is loaded in the suture loading region 5917, 5913. It may alsobe advantageous to hold the second bight under tension. By securing theends 5917, 5916 of this second loop/bight 5909, and by holding it intension, it may be primed for automatically loading into the needleafter the needle has passed the first bight to the opposite jaw, asdescribed above. This is illustrated in FIG. 59B, showing the secondbight 5916 held taught with the ends of the bight 5916, 5917 (notvisible in FIG. 59B) secured to a suture cleat.

Pulling this second suture bight taught as shown in FIG. 59B by holdingthe ends of the suture bight in the cleat may help with automaticallyloading the second bight into the tissue penetrator, as illustrated inFIG. 59C. In this example, the tissue penetrator has been retractedproximally, exposing the opening of the suture retainer region. Tensionon the suture loop, as well as the shape of the suture holder region onthe jaw has driven the suture loop 5909 into the suture retainer region.Thereafter, the tissue penetrator may be withdrawn further proximally,and the suture cleat automatically (or manually) disengaged, releasingthe ends of the second bight so that the second loop is loose, thoughheld in the suture retainer region of the tissue penetrator, as shown inFIG. 59D.

FIGS. 59E-59H show a side view of the distal end of the lower jaw regionshown in FIGS. 59A-59D, in which the loose ends of the second bight aresecured (with slight tension) using a cleat. In FIG. 59E, which is aside view of a jaw member corresponding to the top view shown in FIG.59B, the free ends of the second suture bight are held in tensionagainst the lower jaw 5901 by a cleat 5920. The loop of suture is heldin slight tension, pulling the suture bight proximally within the sutureholding region and preventing it from falling out of the suture loadingregion which may also help pull it into the suture holding region of thetissue penetrator after passing the first bight. For example, in FIG.59F the lower jaw is shown adjacent to a region of tissue 5940; theupper jaw is presumed to be positioned on the opposite side of thisportion of tissue (not shown). The tissue penetrator 5930 is shownextending though the tissue, pushing the first bight through the tissue,while the second bight is held securely in the lower jaw by the cleat.FIG. 59G shows the device and tissue after withdrawing the tissuepenetrator, leaving the first bight in the tissue. The side view of FIG.39G corresponds to FIG. 59C. Thereafter, the tissue penetrator may beretracted proximally to engage the second bight so that it may be passedthrough a different region of the tissue. After retracting the tissuepenetrator and re-loading it with the second bight, one or both ends ofthe second bight may be released from the cleat. In some variations thecleat holding the second bight may be configured to automaticallyrelease one or both ends of the suture, as illustrated in FIG. 59H. FIG.59H is a side view corresponding to the top view of FIG. 59C. In thisexample, retraction of the tissue penetrator (not visible) proximallymay trigger release of the suture from the cleat; in FIG. 59H the cleathas been retracted into the lower jaw, dropping the lengths of suture.In some variations the cleat may pinch or engage the length(s) of sutureby a friction or grasping mechanism, and retraction of the tissuepenetrator and/or loading of the second bight onto the suture passer maycause the release of the lengths of suture from the cleat.

The lengths of suture shown in FIGS. 59A-59H may not be to scale, andmay not be as loose within the body as they are shown. For example, whenusing the device in the region of the meniscus, the suture may be heldbetween the lower jaw member and the tibia/meniscus. For simplicity, thelengths of suture are shown relatively free; in operation within the(more crowded) tissue spaces, the principles described herein apply.

FIG. 60 shows a bottom view of one variation of a suture passer devicesimilar to the variation shown in FIGS. 39A-39D, including a suturemanagement feature (a suture cleat in this example) securing the end ofa bight of suture that has been loaded into the suture passer. In thisexample, a suture cleat 6001 is located on the lower or second jawmember that is axially movable in the long axis of the device. Thus, asthe lower jaw is extended or retracted, the cleat moves with the lowerjaw. In some variations the cleat is a tensioning member that may adjustthe tension on the suture and/or suture loop. One or more suturemanagement features may be included on any appropriate region of thesuture passer, including the first jaw member, second jaw member, tissuepenetrator, elongate member, handle, etc.

As mentioned, a suture cleat may be configured to automatically releasea length(s) of suture, or reduce or release tension on the suture, whenthe second length of suture is ready to be loaded onto the tissuepenetrator. One example of an automatic release cleat is illustrated inFIG. 61A. In this example, the cleat holds two lengths of suture 6101,6102 securely against the outer surface of the lower jaw. In FIGS. 61Aand 61B the suture is shown only in cross-section, where they are heldand released by the cleat. For example, in FIG. 61A, the cleat 6105pinches the lengths of suture 6101, 6102 against the wall 6107 of thelower jaw member. In this example, the cleat is configured as a leafspring that is pre-biased against the lower jaw member; the distal endof the cleat is secured to the lower jaw. The cleat includes an internalcam surface 6115. Pushing against this cam surface may drive the cleataway from the wall of the lower jaw member, allowing the lengths ofsuture to be released, as shown in FIG. 61B. In this example, the cleatis automatically released when the cam surface 6115 is driven against acomplimentary release cam surface 6111 within the lower jaw. In somevariations this release cam surface is part of the tissue penetrator.Thus, as the tissue penetrator is drawn proximally to load the secondbight, this release cam surface (formed as a region of the tissuepenetrator) drives release of the lengths of suture from the cleat. Insome variations a separate lever or other mechanism may be used. Thecleat may also include a more active release mechanism, in which thelengths of suture are driven out of the cleat. For example, a releasecam surface may be driven into the cleat proximally as the tissuepenetrator is withdrawn proximally to load the second bight onto thetissue penetrator, and this release cam surface may drive the suturesout of the cleat.

FIGS. 62A and 62B illustrate another variation of a suture cleat,similar to the variation shown in FIG. 61A. In this example, the suturecleat 6201 is also attached at one side to the lower jaw of the suturepasser 6203, and a suture 6205 is held (clamped) in the jaws at theopposite end of the suture cleat 6201. The clamping region of the cleatmay be deflected away from the lower jaw, as shown in FIG. 62B. In thisexample, the suture (or multiple lengths of suture) can be clamped orheld in the long axis of the clamping region of the cleat. Opening theclamp region allows the suture to be released, as shown in FIG. 62B. Theclamp region of the cleat may be deflected by pushing against a camsurface that is connected to the clamping region. In FIG. 62B the cleatincludes a region 6209 that can be used to deflect the clamping region.Thus, as just described, a suture passer for repairing meniscal tearsmay place two legs of a circumferential stitch with only a singleinsertion of the instrument into the knee. In some variations the suturepasser device may be loaded with two ends of a length of suture into onejaw (i.e. the lower jaw), inserting the suture passer into the knee,having a tissue penetrator pass one suture end up to the other jaw (i.e.the upper jaw) where it is removed off of the tissue penetrator. Thetissue penetrator may then return to the lower jaw and pick up thesecond end of the length of suture. The instrument is placed in anotherlocation, and the tissue penetrator is again advanced, passing thesuture off onto the upper jaw. With both ends of the suture havingtraveled from the lower jaw to the upper jaw, removing the suture passerwill result in a circumferential stitch around the meniscus.

In the above embodiment, one configuration for loading two ends of asingle suture into the suture passer so that a single tissue penetratorcan pass them with sequential advances of the tissue penetrator involvesspecific jaw features. For example, the lower jaw may contain a trackfor guiding the tissue penetrator. One section of the track is cut outleaving a space for a second suture to reside beyond the width of theneedle. The space (suture holding region 4703) is identified in FIG.47A.

In some variations the device includes a control (e.g., switch, lever,button, etc.) that moves the tissue penetrator to assist in loading. Forexample, a suture passer including a proximal handle is shown in FIGS.39C and 48. In the embodiment shown, a suture loading control 4801, tomove the tissue penetrator distally or proximally within the jaw toassist in loading of the pair so suture, is indicated.

The procedure for loading a suture passer may include first loading oneend of the suture into a notch contained on the tissue penetrator (e.g.,FIG. 47A-47C). A suture can be pinched in place by pulling the tissuepenetrator back. Next the other end of the suture may be loaded into thespace that is cut out of the tissue penetrator guiding track. Thissecond end of the suture is pulled taught away from the tissuepenetrator as shown in FIG. 47D. While the second end is pulled taughtinto this space away from the tissue penetrator, the user flips a switchon the handle causing the needle to move distally a small amount.

Once the suture passer has been loaded in the manner as described above,the lower jaw can be retracted. The suture passer can then be insertedinto the joint with the upper jaw placed above the superior surface ofthe meniscus. The lower jaw is then advanced such that the meniscus issurrounded by the lower jaw and upper jaws. The tissue penetrator canthen be advanced out of the lower jaw to pass the first suture legthrough the meniscus. The needle may be advancing with the first sutureleg without the meniscus present, as shown in FIG. 49. In this figure,the second end can be shown waiting to the side of the tissue penetratorin its space at the distal end of the lower jaw

Once the tissue penetrator has passed through the meniscus, it interactswith the inferior surface of the upper jaw which causes the tissuepenetrator to redirect itself tangent to the undersurface of the upperjaw. The tissue penetrator, with the first end of the suture in tow,progresses toward a suture trap which comprises a leaf spring with teethformed at the distal end and another feature of the upper jaw alsocontaining teeth. A cross section of an upper jaw trap is shown in FIG.42B.

In the exemplary jaw member and method of loading and/or using thedevice, the two ends of the suture are loaded into the distal end withtwo bights: one bight for each end. One leg of the bight resides on theinferior surface of the lower jaw, and the other leg resides on thesuperior surface of the lower jaw. Because of the tight space in theknee joint, these legs underneath the inferior surface of the lower jawmay get pinched between the tibia and the lower jaw, restrictingmovement of the sutures during operation.

In some variations, the suture passer is configured to be loaded withone or more sutures so that the bights of the two ends of the sutureboth reside on the superior surface of the lower jaw. FIGS. 50A-50Billustrate schematically two variations in which both legs of a loop ofsuture are held on the same side of the device (e.g., the superiorsurface of the lower jaw) when loaded. These embodiments may includetissue penetrators that have two notches, allowing a suture to wraparound the tissue penetrator so that the suture can originate on thesuperior surface of the lower jaw, wrap around the tissue penetrator,and return on the superior surface of the lower jaw. FIG. 50A shows atissue penetrator having two notches (adjacent to each other) on oneside of the tissue penetrator, and FIG. 50B shows a tissue penetratorhaving two notches on opposite sides of the tissue penetrator. In bothcases the suture loop may wrap around the tissue penetrator so that thelength of suture before and after the loop region extends on the sameside or surface of the suture passer. In both examples, the jaw in whichthe tissue penetrator resides is also adapted for loading the two ormore sutures, and may include a suture loading region (or regions) tohold a suture loop until the suture holder in the tissue penetrator isempty of another suture.

In some variations multiple loops of suture may be sequentiallydelivered with a tissue penetrator in which the tissue penetrator hasmultiple suture retainer regions. In some variations the suture retainerregions are configured as one or more notches. The suture retainerregions may be positioned along the proximal to distal length of thetissue penetrator. For example, in some variations, a second sutureretainer region is positioned proximal to a first suture retainer regionalong the length of the tissue penetrator. In this variation, an exampleof which is shown in FIG. 51, the proximal handle of the suture passermay coordinate travel of the tissue penetrator so that to pass the firstloop of suture in the distal most suture retainer region of the tissuepenetrator, the distal suture retainer (e.g., notch) passes the suturestripper in the upper jaw while the second suture does not (by limitingthe distal extension of the tissue penetrator). This is shown in FIG.51. The second loop of suture is passed by (e.g., via a control on thehandle or automatically) advancing the tissue penetrator more distallyso that the more proximal suture retainer region on the tissuepenetrator extends past the suture stripper in the upper jaw, trappingboth the first and second loops of suture. Another variation of a suturepasser adapted for passing at least two loops of suture (eithersequentially or simultaneously) is shown in FIG. 52. In this example,two tissue penetrators are included in parallel, each one loaded with asuture. In some variations the tissue penetrators are side-by-side asshown in FIG. 52; alternatively, the tissue penetrators may be atop eachother. The sutures may be delivered by extending each (or both) of thetissue penetrators across the tissue and into the second jaw memberwhere a suture stripper can retain the suture(s).

As mentioned above, any of the suture passers described herein could beused for repair of soft tissue in joints, and/or to sew in allografts orartificial soft tissue constructs such as an artificial meniscalscaffold or graft. Although well adapted for meniscus repair, thesedevices and the underlying features of the devices are not limited tomeniscus repair, and may be used and/or adapted for use in other bodyregions, including other joints. For example, the shape and/ordimensions of the jaw members may be adapted for use with other bodyregions, such as the radiusing (curve) of the upper jaw member, thethickness of the upper jaw member, and the like.

In some variations the suture passer devices include a suture puller orsuture capture element for capturing and/or pulling a portion of asuture from the distal end of the suture passer toward the proximal endafter it has been passed between the distal-facing jaws. FIGS. 53A-53Lillustrate one variation of a suture passer and method of using thesuture passer to form a loop of suture through a tissue that uses asuture puller/suture capture element (which may be referred to as asuture capture and pull element or suture snare). In this example, thesuture passer may be similar to the suture passers described above, withthe addition of a suture snare on the upper jaw member configured tocapture and pull the suture proximally after it has been passed from thelower to the upper jaw. In FIG. 53A, the suture snare 5305 is positionedwhere the previously described suture stripper is located, and mayfunction like a suture stripper. The lower jaw is loaded with a lengthof suture 5303 having a long end and a short end. The tissue penetratorin the lower jaw initially extends from the lower jaw carrying the loopof suture, as shown in FIG. 53B (the jaws of the suture passer may bepositioned around the tissue in any appropriate manner, including thosedescribed above using pivoting upper jaw and axially extending lower jawmembers). The tissue penetrator extends with the suture into the upperjaw and the distal end of the tissue penetrator extends distally from anopening in the upper jaw member, which allows the region of the tissuepenetrator including the suture (the suture retainer region) to extendpast the suture snare, as shown in FIG. 53C. Withdrawal of the tissuepenetrator from the upper jaw and back into the lower jaw (along thesigmoidal path shown) results in the loop of suture being captured inthe upper jaw by the suture snare, as shown in FIG. 53D. In thisexample, the suture snare is configured as a sheet of metal (configuredto have a finger or teeth to help retain the suture) that detains thesuture in the upper jaw. The suture snare may then be used to draw theend of the suture proximally, as shown in FIG. 53E. In some variationsone end of the suture is pulled proximally out of the patient; in othervariations the end of the suture is pulled only partially along theupper jaw. The suture may then be tensioned in the upper jaw. In somevariations the suture snare may apply tension, in other variations thesuture may be manually tensioned. As shown in FIG. 53G, the suturepasser may then be repositioned on the tissue so that the rest of theloop of suture may be formed (e.g., around a tear in the tissue). As isapparent from the figures, the tissue shown in the example of FIGS.53A-L is meniscal tissue; however any appropriate tissue may be suturedusing the device and method.

Once the suture passer is repositioned, the tissue penetrator may thenbe extended through the tissue to engage the end of the suture held inthe upper jaw, as shown in FIGS. 53H and 531. The tissue penetrator maybe configured as a push/pull tissue penetrator. FIG. 531 illustrates onevariation of a push/pull tissue penetrator 5309 that may be used. Inthis example, the tissue penetrator includes dual suture retainerregions: one for retaining the suture as it is driven from the lower tothe upper jaw, and one for retaining the suture as it is withdrawn fromthe upper to the lower jaw. In some variations the tissue penetrator isconfigured so that a single suture retainer region can hold the suturein both directions. For example, a hook region may be configured to holdthe suture in both directions.

In FIG. 53J the suture has been pulled back to the lower jaw andcaptured by the lower jaw (e.g., within the tissue penetrator and/or asuture capture region and/or suture stripper in the lower jaw). Thedevice may then be removed from the tissue, as shown in FIG. 53K,pulling the loose end of the suture through the tissue and creating aloop passing through the tissue, as shown in FIG. 53L. The ends of thesuture may then be knotted (e.g., to each other), completing the loop.

Another variation of a suture passer including a suture snare is shownin FIG. 54A. In this example, the suture passer include a distal facingopening formed from a pivoting upper jaw and an axially sliding lowerjaw, and a suture snare 5405 on the lower jaw configured as a loop thatmay be withdrawn (via a snare cord) proximally after passing the firstsuture bight. In this example the suture snare is connected at theproximal handle to a rip cord and rip cord tag 5407. This variation ofthe device may be loaded (e.g., preloaded) with a suture in the upperjaw member. FIG. 54B shows an enlarged view of the distal end of thedevice, The upper jaw is configured to be pre-loaded with a suture thatcan be held in tension in the upper jaw. The lower jaw houses the tissuepenetrator that is configured to move in a sigmoidal path as well as thesuture snare described above. The end of the tissue penetrator may passthrough the snare as it extends and retracts, allowing it to choke ontothe suture after it has been passed, as illustrated in FIGS. 55A-55DD.

In operation, the suture passer device of FIG. 54A may be used pass asuture in a loop around a target tissue (e.g., meniscus). For example,in FIG. 55A, the distal end of the device is first inserted into theknee. The suture is preloaded (or has already been loaded) on the upperjaw and tensioned (e.g., cleated) so that the suture has sufficienttension to allow it to be engaged by the tissue penetrator and drawndown through the tissue.

FIGS. 55B to 55D show positioning of the tissue passer around the targettissue. In positioning the device, the clamping trigger on the handlecan be used to control the rotation of the upper jaw, as shown in FIGS.55A and 55B. Thus, the upper jaw can be positioned immediately adjacentto the tissue to be sutured, and the tissue can be clamped in the mouthof the device after using the handle to extend the lower jaw member bydepressing a control (e.g., a lower jaw trigger control on the handle)as shown in FIGS. 55C and 55D. The device may be positioned andrepositioned until it is positioned as desired. In any of the methodsdescribed herein, imaging (e.g., arthroscopy) can be used to guide theprocedure.

Once in position, the needle may be deployed, as shown in FIG. 55E. Inthis example, the lower jaw trigger is also configured to extend thetissue penetrator after the control has already been actuated to extendthe lower jaw. The second actuation of the control results in the needlebeing extended in a sigmoidal path from the lower jaw, through thetissue, and to the upper jaw, where it can extend beyond the distal tipand pull back the suture to the first jaw, though the mouth of thesuture snare. FIG. 55F illustrates a device such as the oneschematically illustrated in FIGS. 55A-E, in which the tissue penetratoris pulling a loop of suture loaded in the upper jaw to the lower jaw.The suture is then pulled through the eye of the snare as shown in FIG.55G. The tissue penetrator may continue to pull the suture, which can beremoved from tension in the upper jaw as shown in FIG. 55H by uncouplingthe suture from a tensioner (cleat) on the device. As shown in FIG. 55I,a rip cord pull 5511, may be present on the handle of the device, andmay be pulled to tighten and/or withdraw the snare from the distal endof the device towards the proximal end. This is illustrated in FIGS. 551(showing pulling of the snare/ripcord) and FIGS. 55J (before pullingsnare/ripcord) and FIG. 55K (showing pulling of the snare/ripcord). Thetissue penetrator may release the suture so that the end of the suturecan be withdrawn proximally as the snare is withdrawn proximally. As thesnare pulls the suture proximally, the suture may play out over theupper jaw, pulling the suture through the meniscus. The snare pulls thebody of the suture outside of the knee, as shown in FIG. 55N.

In some variations, the suture passer may monitor the pulling of thesnare (e.g., ripcord), activating an internal mechanism that determinesthe timing of the suture's release from the lower jaw (e.g., tissuepenetrator), as shown in FIG. 55O. After a predetermined time ordistance of pulling the ripcord, the snare mechanism (shown in FIG. 55P)eventually releases the snare. This may be accomplished by gearingwithin the handle (FIG. 55Q). Prior to release, the suture may be heldin the lower jaw with the tissue penetrator, as shown in FIG. 55R.Towards the end of the snare pulley mechanism, an internal gear maytrigger the tissue penetrator to switch to a release position. A releasewindow may be present in the lower jaw. The needle may retract to thiswindow near the end of the snare mechanisms travel, as shown in FIGS.55S-55T. The suture body that has been pulled out of the knee may thenbe grasped by the surgeon, as shown in FIG. 55U; the surgeon maycontinue to pull the suture end out of the knee. In some variations, thesuture may be drawn from the knee until the end of the suture is beyondthe upper jaw member, as shown in FIGS. 55V and 55W. The passed end ofthe suture may be fully withdrawn, as shown in FIG. 55X. The suture (andparticularly the portion of the suture in the upper jaw) may then bepulled to apply tension, as shown in FIG. 55Y. The end of the suturethat was not withdrawn from the knee may be attached to a tensioningelement (e.g., tensioner, cleat, etc.).

The device can then be repositioned around the tissue, as shown in FIG.55Z, so that it is positioned in the second fire position. The tissuepenetrator may then be extended across the tissue to engage the suturein the upper jaw member, then retracted back through the tissue so thatthe suture loop is again secured in the lower jaw member, as shown inFIG. 55AA. The device may then be retracted, leaving the loop of suturein place, For example, in FIG. 55BB, the lower jaw (with one end of thesuture attached) may be retracted, and the entire device may bewithdrawn from the knee, as shown in FIG. 55CC. Finally, the end of thesuture may be removed from the device, and the suture may be tied off.The knot may be tied outside of the knee to complete the stitch, asshown in FIG. 55DD.

Although many of the variations of the devices illustrated above includeinternal deflection regions for directing the shape of the path taken bythe tissue penetrator, the deflection regions may be external orpartially external. For example, in some variation the tissue penetratorextends distally beneath the upper jaw, rather than entering into theupper jaw; a suture may be picked up and/or dropped off in the upper jawfrom this external position.

In general, the devices described herein may be sized and configured toeasily insert to repair tissue into even difficult to access regions,including joint regions such as the knee, shoulder and hip. As mentionedabove the upper and/or lower jaw may be relatively thin. For example, insome variations the upper jaw thickness, which may also be referred toas the height of the upper jaw, may be less than about 0.120 inches(e.g., less than 0.1 inch, less than 0.08 inches, less than 0.07 inches,less than 0.06 inches, etc.). In some variations the height or thicknessof the upper jaw is between about 0.064″-0.120″. FIGS. 56A-56Cillustrate variations of the upper jaw having different heights orthicknesses. For example, in FIG. 56A, the upper jaw member has amaximum height of approximately 0.120 inches. This variation of thefirst (or upper) jaw member is similar to that shown in FIGS. 1-8. Inthis variation the upper jaw member includes a limiter that limits theextension of the tissue penetrator from the upper jaw. In FIG. 56B theupper jaw member has as maximum height of approximately 0.085 inches,and is curved. This variation is similar to that described above inFIGS. 16A-16C and 37A-37B. FIG. 56C shows another variation of an upperjaw member having a maximum height of approximately 0.064 inches. Thisvariation is similar to that shown in FIGS. 40A-40B, 40D and 42A-42B. Asshown, any of these variations may also be curved, and may be hingedand/or pivotally connected to an elongated member extending from ahandle.

The width of the jaw member (upper and/or lower) may be greater than theheight/thickness of the jaw member. In some variations the jaw memberhas a width that is more than twice its height (e.g., between about 0.4and about 0.1 inches). The width may be less of a constrainingdimension, as there may be sufficient space in the joint from side toside; the size constraint may be the space from top to bottom (height)in joints such as the knee.

FIG. 57 shows a comparison between two variations of the lower (e.g.,second) jaw members. In FIG. 57, one of the lower jaw members is shownhaving a height of about 0.17″. For comparison, another variation of thelower jaw member having a height of approximately 0.11″ is shown infront of the taller member. In general, the jaw member may have a heightthat is less than about 0.2″, less than 0.18″, less than about 0.17″,less than about 0.15″, less than about 0.13″, less than about 0.11″,less than about 0.10″, etc. The lower jaw member may house the tissuepenetrator and may include a deflection region for deflecting the tissuepenetrator so that it exits the lower jaw member nearly perpendicularlyfrom the proximal-to-distal elongate axis of the lower jaw member.

Although many of the variations of suture passer devices describedherein are configured so that the tissue penetrator extends distallyfrom an opening in a jaw, any of the suture passers described herein maybe configured so that the tissue penetrator extends proximally afterextending between the upper and lower jaws. Thus, the deflectionfeatures on the upper jaw could be set to facilitate the needle headingin the proximal direction. For example, in some variations the tissuepenetrator extends proximally within (or out of) the upper jaw memberafter extending across the opening between the jaws. In some variationsthe tissue penetrator extends along an internal channel within theopposite (upper) jaw member, as illustrated in FIG. 58. In thisvariation the upper jaw member includes a deflector that deflects thetissue penetrator proximally (towards the proximal handle direction).Thus a suture may be pushed or pulled while the tissue penetrator isgiven sufficient clearance to pass the suture. Suture passers moving inthis manner may be referred to as having a “U” shaped (or 180°) pathway.

Although the description above is broken into parts and includesspecific examples of variations of suture passers, any of the featuresor elements described in any particular example or section may beincorporated into any of the other embodiments. Although the foregoinginvention has been described in some detail by way of illustration andexample for purposes of clarity of understanding, it is readily apparentto those of ordinary skill in the art in light of the teachings of thisinvention that certain changes and modifications may be made theretowithout departing from the spirit or scope of the appended claims.

What is claimed is:
 1. A suture passer device having a suture-passingtissue penetrator that travels in a sigmoidal pathway, the devicecomprising: a first jaw member extending distally from an elongate body,wherein the first jaw member includes a deflection surface and a distalopening; a second jaw member extending distally from the elongate body,wherein the first jaw member and the second jaw member form adistal-facing mouth; and a tissue penetrator configured to extend fromthe second jaw member, across the distal-facing mouth, into the firstjaw member, deflect against the deflection surface and extend distallyfrom the distal opening of the first jaw member.